Reports and guidance documents; availability, etc.: Guidance documents; quarterly list,
[Federal Register: January 6, 1999 (Volume 64, Number 3)]
[Notices]
[Page 888-903]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja99-71]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0046]
Quarterly List of Guidance Documents at the Food and Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is publishing a quarterly update of all guidance documents issued and withdrawn since the compilation of the quarterly list that published on July 6, 1998. FDA committed to publishing quarterly updates in its February 1997 ``Good Guidance Practices'' (GGP's), which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. This list is intended to inform the public of the existence and availability of guidance documents issued during this quarter. This list also includes some guidance documents that were inadvertently not included on previously published lists.
DATES: General comments on this list and on agency guidance documents are welcome at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Information on where to obtain single copies of listed guidance documents is provided for each agency center individually in the specific center's list of guidance documents.
FOR FURTHER INFORMATION CONTACT: Lisa L. Barclay, Office of Policy (HF- 22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360.
SUPPLEMENTARY INFORMATION:
-
Background
In the Federal Register of February 27, 1997 (62 FR 8961), FDA published a notice announcing its ``Good Guidance Practices'' (GGP's), which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. The agency adopted the GGP's to ensure public involvement in the development of guidance documents and to enhance public understanding of the availability, nature, and legal effect of such guidance.
As part of FDA's effort to ensure meaningful interaction with the public regarding guidance documents, the agency committed to publish an annual comprehensive list of guidance documents and quarterly Federal Register notices that list all guidance documents that were issued and withdrawn during that quarter, including ``Level 2'' guidance documents. The following list of guidance documents represents all guidances issued or withdrawn by FDA since the compilation of the July 6, 1998 (63 FR 36413) quarterly list and any guidance documents inadvertently not included on previously published lists. The guidance documents are organized by the issuing Center or Office within FDA, and are further grouped by the intended users or regulatory activities to which they pertain. Dates provided in the following list refer to the date of issuance or, where applicable, the date of last revision of the document. Document numbers are provided where available.
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Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)
[[Page 889]]
How to Obtain a Hard Copy of the Document Name of Document
Date of Issuance
Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or Regulatory Activity
Internet)
Draft Guidance for Industry: Manufacturing, March 1998
FDA Regulated Industry
Office of Communication, Training, and Processing or Holding Active
Manufacturers Assistance (HFM-40), Center Pharmaceutical Ingredients
for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852- 1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.)or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber Draft Guidance for Industry: Instructions May 1998
Do
Do for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research Draft Guidance for Industry: Pilot Program May 1998
Do
Do for Electronic Investigational New Drug (eIND) Applications for Biological Products Draft Guidance for Industry: Electronic May 1998
Do
Do Submissions of Case Report Forms (CRF's), Case Report Tabulations (CRT's) and Data to the Center for Biologics Evaluation and Research Draft Guidance for Industry: Electronic May 1998
Do
Do Submissions of a Biologics License Application (BLA) or Product License Application (PLA)/Establishment License Application (ELA) to the Center for Biologics Evaluation and Research Guidance for Industry: Submitting and
May 1998
Do
Do Reviewing Complete Responses to Clinical Holds Guidance for Industry: Classifying
May 1998
Do
Do Resubmissions in Response to Action Letters Guidance for Industry: Pharmacokinetics in May 1998
Do
Do Patients with Impaired Renal Function-- Study Design, Data Analysis and Impact on Dosing and Labeling Guidance for Industry: Standards for the May 1998
Do
Do Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements Guidance for Industry: Providing Clinical May 1998
Do
Do Evidence of Effectiveness for Human Drugs and Biological Products Draft Guidance for Industry: Stability June 1998
Do
Do Testing of Drug Substances and Drug Products ICH Draft Guidance on Specifications: Test June 9, 1998
Do
Do Procedures and Acceptance Criteria for Biotechnological/Biological Products ICH Guidance on Ethnic Factors in the
June 10, 1998
Do
Do Acceptability of Foreign Clinical Data Draft Guidance for Industry: Exports and June 12, 1998
Do
Do Imports Under the FDA Export Reform and Enhancement Act of 1996 Draft Guidance for Industry: Content and June 1998
Do
Do Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product Guidance for Industry: Qualifying for
June 1998
Do
Do Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act
[[Page 890]]
Draft Guidance for Industry: In the
July 1998
Do
Do Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Virus Type 1 Draft Guidance for Industry: For the
July 1998
Do
Do Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the FDA Form 356h ``Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use'' Guidance for Industry: Implementation of July 1998
Do
Do Section 126 of the Food and Drug Administration Modernization Act of 1997-- Elimination of Certain Labeling Requirements Guidance for Industry: Environmental
July 1998
Do
Do Assessment of Human Drug and Biologics Applications Draft Guidance for Industry:
July 1998
Do
Do Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods Draft Guidance for Industry: Content and August 1998
Do
Do Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test ICH Guidance on Statistical Principles for September 16, 1998
Do
Do Clinical Trials ICH Guidance on Quality of Biotechnological/ September 21, 1998
Do
Do Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/ Biological Products Guidance for Industry: Current Good
September 1998
Do
Do Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti- HCV ICH Guidance on Viral Safety Evaluation of September 24, 1998
Do
Do Biotechnology Products Derived From Cell Lines of Human or Animal Origin Guidance for Industry: Errors and Accidents June 1998
Do
Do Regarding Saline Dilution of Samples Used for Viral Marker Testing (Level 2) Guidance for Industry: How to Complete the September 1998
Do
Do Vaccine Adverse Reporting System Form (VAERS-1) (Level 2)
Withdrawn
Guidance for Industry: Supplemental Testing September 1998
Do
Do and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)--March 1998
[[Page 891]]
Memorandum: Revised Precautionary Measures September 1998
Do
Do to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products-- December 11, 1996 (Partial Withdrawal) (Withdrawal of recommendations pertaining to retrieval, quarantine, destruction, and notification for plasma derivatives)
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Guidance Documents Issued by the Center for Devices and Radiological (CDRH)
How to Obtain a Hard Copy of the Document Name of Document
Date of Issuance
Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or Regulatory Activity
Internet)
Medical Devices: Draft Global Harmonization July 16, 1998
Office of Compliance (OC)
Division of Small Manufacturers Task Force Study Group 3 Process
Assistance, 1-800-638-2041 or 301-827- Validation Guidance (Draft)
0111 or (FAX) Facts-on-Demand at 1-800- 899-0381 or Internet at http:// www.fda.gov/cdrh Global Harmonization Task Force: Draft October 28, 1998
Do
Do Document on the Essential Principles of Safety and Performance of Medical Devices on a Global Basis Global Harmonization Task Force:
August 31, 1998
OC/Office of Surveillance and
Do Availability of Draft Documents on Adverse
Biometrics (OSB) Event and Vigilance Reporting of Medical Device Events Guidance for Industry--Contents of a PDP April 25, 1998
Office of Device Evaluation (ODE) Medical Device Labeling--Suggested Format May 9, 1997
Do
Do and Content Guidance for the Content of Premarket
May 28, 1998
Do
Do Submissions for Software Contained in Medical Devices (replaces Reviewer Guidance for Computer-Controlled Medical Devices Undergoing 510(k) Review 8/29/91) New Model Medical Device Development
June 3, 1998
Do
Do Process Modifications to Devices Subject to
August 6, 1998
Do
Do Premarket Approval the PMA Supplement Decision Making Process Guidance for Off-the Shelf Software Use in August 17, 1998
Do
Do Medical Devices Convenience Kits Interim Regulatory
May 20, 1997
Do
Do Guidance Kit Certification for 510(k)s
July 1997
Do
Do Guidance to Industry Supplements to
May 20, 1998
Do
Do Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review 30-Day Notices and 135-Day PMA Supplements February 19, 1998
Do
Do for Manufacturing Method or Process Changes, Guidance for Industry and CDRH Procedures for Class II Device Exemptions February 19, 1998
Do
Do from Premarket Notification, Guidance for Industry and CDRH Staff Guidance for Submission of
June 6, 1998
ODE/Division of Clinical Laboratory Do Immunohistochemistry Applications to the
Devices (DCLD) FDA
[[Page 892]]
In Vitro Diagnostic Creatinine Test System July 2, 1998
Do
Do In Vitro Diagnostic Bicarbonate/Carbon July 6, 1998
Do
Do Dioxide Test System In Vitro Diagnostic Chloride Test System July 6, 1998
Do
Do In Vitro Diagnostic Glucose Test System July 6, 1998
Do
Do In Vitro Diagnostic Potassium Test System July 6, 1998
Do
Do In Vitro Diagnostic Sodium Test System July 6, 1998
Do
Do In Vitro Diagnostic Urea Nitrogen Test July 6, 1998
Do
Do System In Vitro Diagnostic C-Reactive
July 20, 1998
Do
Do Immunological Test System In Vitro Diagnostic Calibrators
July 20, 1998
Do
Do Points To Consider For Hematology Quality September 30, 1997
Do
Do Control Materials Points to Consider for Approval of Home September 16, 1997
Do
Do Drugs of Abuse Test Kits Draft Review Criteria for Assessment of
November 6, 1996
Do
Do Professional Use Human Chorionic Gonadotropin (hCG) in Vitro Diagnostic Devices (IVD's) Letter to IVD Manufacturers on Streamlined December 22, 1997
Do
Do PMA Reviewer Guidance for Premarket
July 19, 1995
ODE/Division of Cardiovascular, Do Notification (510(k)) Submissions--
Respiratory, and Neurological Labeling, Performance and Environmental
Devices (DCRND) Testing for Electronic Devices Draft Guidance for Format and Content for July 19, 1995
Do
Do Premarket Notification 510(k) Guidance on the Content and Format of
December 18, 1997
ODE/Division of Dental, Infection Do Premarket Notifications [510(k)]
Control, and General Hospital Submissions for Liquid Chemical Sterilants
Devices (DDIGD) and High Level Disinfectants Guidance on the Content and Format of
January 16, 1998
Do
Do Premarket Notification [510(k)] Submissions for Surgical Masks Guidance on the Content and Format of
February 13, 1998
Do
Do Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Latex Products CDRH Regulatory Guidance Document for
April 27, 1998
Do
Do Preamendments Unclassified Washers and Washer-Disinfectors Intended for Processing Reusable Medical Devices Guidance on the Content and Format of
August 4, 1998
Do
Do Premarket Notification [510(k)] Submissions of Washers and Washer- Disinfectors Devices for the Treatment and/or Diagnosis June 10, 1998
Do
Do of Temporomandibular Joint Dysfunction and/ or Orofacial Pain Dental Impression Materials Premarket
August 17, 1998
Do
Do Notification OTC Denture Cushions, Pads, Reliners,
August 18, 1998
Do
Do Repair Kits, and Partially Fabricated Denture Kits Dental Cements Premarket Notification
August 18, 1998
Do
Do Further Information on the Regulation of August 18, 1997
Do
Do Liquid Chemical Sterilants and High Level Disinfectants Letter to Orthopedic Surgical Manufacturers November 26, 1997
ODE/Division of General and
Do Association
Restorative Devices (DGRD) Letter to the Health Industry Manufacturers November 26, 1997
Do
Do Association
[[Page 893]]
Guidance Document for Industry and CDRH March 18, 1998
Do
Do Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices (Replaces: Guidance Document for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices 8/12/88) Guidance for Content of Premarket
April 28, 1998
Do
Do Notifications for Esophageal and Tracheal Prostheses Guidance Document for Surgical Lamp 510ks July 13, 1998
Do
Do Retinoscope Guidance
July 8, 1998
ODE/Division of Opthalmic Devices Do (DOD) Opthalmoscope Guidance
July 8, 1998
Do
Do Slit Lamp Guidance
July 8, 1998
Do
Do Revised Procedures for Adding Lens
August 11, 1998
Do
Do Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lens for Extended Wear Third Party Review Guidance for Vitreous January 31, 1997
Do
Do Aspiration and Cutting Device Premarket Notification (510K) Third Party Review Guidance for
January 31, 1997
Do
Do Phacofragmentation System Device Premarket Notification (510K) Dear Sponsor Letter Concerning the
May 20, 1997
Do
Do Revocation of 21 CFR part 813 IOL IDE Regulations Guidance for the Content of Premarket
August 7, 1998
ODE/Division of Reproductive
Do Notification for Conventional and High
Abdominal, ENT, and Radiological Permeability Hemodialyzers (replaces:
Devices (DRAERD) Guidelines for Premarket Testing of New Conventional Hemodialyers, High Premeability Hemodialyzers and Hemofilters) Uniform Contraceptive Labeling
July 23, 1998
Do
Do Guidance for the Content of Premarket
August 7, 1998
Do
Do Notifications for Conventional and High Permeability Hemodialyzers Guidance for Industry and CDRH Reviewers on August 7, 1998
Do
Do the Content of Premarket Notifications for Hemodialysis Delivery Systems Devices Used for In Vitro Fertilization and September 10, 1998
Do
Do Related Assisted Reproduction Procedures Letter to Manufacturers of Falloposcopes September 5, 1996
Do
Do Letter to Manufacturers of Prescription September 6, 1996
Do
Do Home Monitors for Non-Stress Tests Continuing Education Credits for Reading/ April 17, 1998
Office of Health and Industry
Do Writing Articles/Papers and Presenting
Programs (OHIP)/Division of Courses/Lectures
Mammography Quality and Radiation Programs (DMQRP) Accidental Radioactive Contamination of August 13, 1998
Do
Do Human Food and Animal Feeds: Recommendations for State and Local Agencies Additional Mammography Review Policy
March 26, 1998
Do
Do Guidance For Review of Cases of Possible March 26, 1998
Do
Do Suspension or Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act, 42. U.S.C. section 263b
[[Page 894]]
Guidance for Review of Requests for
March 26, 1998
Do
Do Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42. U.S.C. section 263b Guidance for Submission of Requests for March 26, 1998
Do
Do Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42. U.S.C. section 263b Supplement to ``The Physician's Continuing April 9, 1998
Do
Do Experience Requirement'' Requalification for Interpreting
May 28, 1998
Do
Do Physician's Continuing Experience MQSA Policy Statements in a Question and June 2, 1998
Do
Do Answer Compliance Guidance: The Mammography
July 8, 1998
Do
Do Quality Standards Act Final Regulations MQSA Policy Statements for the Interim August 6, 1998
Do
Do Regulations Policy for Facilities Changing
April 15, 1998
Do
Do Accreditation Bodies Guidance on FDA's Expectations of Medical May 15, 1998
Office of Science and Technology Do Device Manufacturers Concerning the Year
(OST)/ Division of Electronics and 2000 Date
Computer Science (DESC) Immunotoxicity Testing
1996
OST/Division of Life Sciences (DLS) Do Guidance on the Recognition and Use of February 19, 1998
OST/Office of the Director (OD) Do Consensus Standards
Deletions
Biotechnology and FDA Regulation of
January 1, 1986
ODE
Do Hybridoma In-Vitro Diagnostic Products: List of Current Devices and Guidelines for Manufacturers DCRND--Draft Guidance for Format and
July 19, 1995
ODE/DCRND
Do Content for Premarket Notification 510(k) [replaces 908] [cardiovascular, respiratory, neurological] Guidance for Safety and Effectiveness Data March 1, 1983
Do
Do Required in Premarket Notification (510(k)) Applications for Blood Oxygenators Automated Defibrillators: Operator's Shift August 8, 1991
Do
Do Checklist and Manual Defibrillators: Operator's Shift Checklist Guidance for the Preparation and Content of December 4, 1987
Do
Do Applications to the Food and Drug Administration for Ventricular Assist Devices and Total Artificial Hearts (draft) Guidance Document for the Preparation of August 12, 1988
ODE/DGRD/ORDB
Do IDE and PMA Applications for Bone Growth Stimulator Devices Reviewer Guidance for Computer Controlled August 29, 1991
ODE
Do Medical Devices Undergoing 510(k) Review Guidelines for Premarket Testing of New March 1, 1982
ODE/DRAERD/GRDB
Do Conventional Hemodialyzers, High Permeability Hemodialyzers, and Hemofilters Frequently Asked Questions on Recognition February 19, 1998
OST
Do of Consensus Standards
Corrections
[[Page 895]]
Determining Equivalence of Intraaortic December 8, 1993
ODE/DCRND
Do Balloon Catheters Under the 510(k) Regulations Guidance for the Preparation of the Annual September 1, 1990
Do
Do Report to the PMA Approved Heart Valve Prostheses Electrocardiograph (ECG) Electrode
February 11, 1997
Do
Do Electrocardiograph (ECG) Lead Switching February 11, 1997
Do
Do Adapter Electrocardiograph (ECG) Surface Electrode February 11, 1997
Do
Do Tester Reviewer Guidance for Nebulizers, Metered October 1, 1993
Do
Do Dose Inhalers, Spacers and Actuators Reexamination of the Evaluation Process for May 19, 1997
ODE/DDIGD
Do Liquid Chemical Sterilant and Height Level Disinfectants FDA Guidelines for Multifocal Intraocular May 29, 1997
ODE/DOD
Do Lens IDE Studies and PMAs Information for Manufacturers Seeking
September 30, 1997
ODE/DRAERD/RDB
Do Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Tympanostomy Tubes, Submission Guidance for January 14, 1998
ODE/DRAERD
Do a 510(k) Premarket Notification
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Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
How to Obtain a Hard Copy of the Document Name of Document
Date of Issuance
Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or Regulatory Activity
Internet)
Topical Dermatological Drug Product NDA's June 18, 1998
Biopharmaceutic
Office of Training and Communication, Drug and ANDA's--In Vivo Bioavailability,
Information Branch, Food and Drug Bioequivalence, In Vitro Release and
Administration, 5600 Fishers Lane, Associated Studies, Draft
Rockville, MD 20857. Internet access: http://www.fda.gov/cder/guidance/ index.htm Buspirone Hydrochloride Tablets In Vivo May 15, 1998
Do
Do Bioequivalence and In Vitro Dissolution Testing SUPAC IR/MR: Immediate Release and Modified April 28, 1998
Chemistry
Do Release Solid Oral Dosage Forms Manufacturing Equipment Addendum, Draft Stability Testing of Drug Substances and June 8, 1998
Do
Do Drug Products, Draft PAC-ATLS: Postapproval Changes- Analytical April 28, 1998
Do
Do Testing Laboratory Sites Environmental Assessment of Human Drugs and July 27, 1998
Do
Do Biologics Applications Uncomplicated and Complicated Skin and Skin July 22, 1998
Clinical Antimicrobial Guidances Do Structure Infections; Developing Antimicrobial Drugs for Treatment, Draft Acute Bacterial Meningitis; Developing July 22, 1998
Do
Do Antimicrobial Drugs for Treatment, Draft Uncomplicated Gonorrhea--Cervical,
July 22, 1998
Do
Do Urethral, Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment, Draft Complicated Urinary Tract Infections and July 22, 1998
Do
Do Pylonephritis; Developing Antimicrobial Drugs for Treatment, Draft
[[Page 896]]
Streptococcal Pharyngitis and Tonsillitis; July 22, 1998
Do
Do Developing Antimicrobial Drugs for Treatment, Draft Secondary Bacterial Infections of Acute July 22, 1998
Do
Do Bronchitis; Developing Antimicrobial Drugs for Treatment, Draft Uncomplicated Urinary Tract Infections; July 22, 1998
Do
Do Developing Antimicrobial Drugs for Treatment, Draft Nosocomial Pneumonia; Developing
July 22, 1998
Do
Do Antimicrobial Drugs for Treatment, Draft Vulvovaginal Candidiasis; Developing
July 22, 1998
Do
Do Antimicrobial Drugs for Treatment, Draft Lyme Disease; Developing Antimicrobial July 22, 1998
Do
Do Drugs for Treatment, Draft Empiric Therapy of Febrile Neutropenia; July 22, 1998
Do
Do Developing Antimicrobial Drugs for Treatment, Draft Community Acquired Pneumonia; Developing July 22, 1998
Do
Do Antimicrobial Drugs for Treatment, Draft Bacterial Vaginosis; Developing
July 22, 1998
Do
Do Antimicrobial Drugs for Treatment, Draft Acute Otitis Media; Developing
July 22, 1998
Do
Do Antimicrobial Drugs for Treatment, Draft Acute Bacterial Sinusitis; Developing
July 22, 1998
Do
Do Antimicrobial Drugs for Treatment, Draft Acute Bacterial Exacerbation of Chronic July 22, 1998
Do
Do Bronchitis; Developing Antimicrobial Drugs for Treatment, Draft General Considerations for Clinical Trials; July 22, 1998
Do
Do Developing Antimicrobial Drugs for Treatment, Draft Acute or Chronic Bacterial Prostatitis; July 22, 1998
Do
Do Developing Antimicrobial Drugs for Treatment, Draft Submission of Abbreviated Reports and
September 21, 1998
Clinical Medical
Do Synopses in Support of Marketing Applications; Draft Developing Medical Imaging Drugs and
October 13, 1998
Do
Do Biologics Providing Clinical Evidence of
May 15, 1998
Do
Do Effectiveness for Human Drug and Biological Products Pharmacokinetics and Pharmacodynamics in May 15, 1998
Clinical Pharmacology
Do Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling Manufacture, Processing or Holding of
April 17, 1998
Compliance
Do Active Pharmaceutical Ingredients, Draft Investigating Out of Specification (OOS) September 30, 1998
Do
Do Test Results for Pharmaceutical Production ANDA's: Impurities in Drug Substances, July 24, 1998
Generic Drug
Do Draft E5 Ethnic Factors in the Acceptability of June 10, 1998
ICH Efficacy
Do Foreign Clinical Data, Draft E9 Statistical Principles for Clinical September 16, 1998
Do
Do Trials Q6B Specifications: Test Procedures and June 9, 1998
ICH Quality
Do Acceptance Criteria for Biotechnological/ Biological Products, Draft Q5D Quality of Biotechnological/Biological September 21, 1998
Do
Do Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products Q5A Biotechnological/Biological
September 24, 1998
Do
Do Pharmaceutical Products; Viral Safety Evaluation
[[Page 897]]
OTC Topical Drug Products for the Treatment July 16, 1998
Labeling
Do of Vaginal Yeast Infections (Vulvovaginal Candidiasis), Draft Dipirefrin Hydrochloride Opthalmic Solution October 1, 1998
Do
Do USP Non-Contraceptive Estrogen Class Labeling October 15, 1998
Do
Do Submitting Debarment Certification
October 2, 1998
Procedural Guidances
Do Statements, Draft National Uniformity for Nonprescription April 9, 1998
Do
Do Drugs Ingredient Labeling for OTC Drugs Standards for the Prompt Review of Efficacy May 15, 1998
Do
Do Supplements, Including Priority Efficacy Supplements Repeal of Section 507 of the Federal Food, June 15, 1998
Do
Do Drug, and Cosmetic Act Qualifying for Pediatric Exclusivity Under June 29, 1998
Do
Do Section 505A of the Federal Food, Drug, and Cosmetic Act 180-Day Generic Drug Exclusivity Under the July 14, 1998
Do
Do Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act Implementation of Section 126, Elimination July 21, 1998
Do
Do of Certain Labeling Requirements of the FDA Modernization Act of 1997 Advisory Committees: Implementing Section November 2, 1998
Do
Do 120 of the FDA Modernization Act of 1997 Submitting and Reviewing Complete Responses May 14, 1998
User Fee
Do to Clinical Holds Classifying Resubmissions in Response to May 14, 1998
Do
Do Action Letters
Withdrawn
Pharmacokinetic Considerations in Drug
Biopharmaceutic Studies Carbamazepine (tablets) In Vivo
January 20, 1988
Do Bioequivalence and In Vitro Dissolution Testing Evaluation of Controlled Release Drug
April 18, 1984
Do Products; Division Guidelines Approaches to Statistical Data Analysis of November 11, 1985
Do Bioavailability/Bioequivalence Studies Controlled Release Dosage Forms: Issues and September 10, 1985
Do Controversies (Conference Report) Submission of Data for Bioequivalence
Do Studies in Computer Format Albuterol Inhalation Aerosols (Metered Dose January 27, 1994
Do Inhalers) In Vivo Bioequivalence and In Vitro Dissolution Testing Albuterol Sulfate (tablets) In Vivo
May 29, 1987
Do Bioequivalence and In Vitro Dissolution Testing Amoxapine (tablets) In Vivo Bioequivalence August 5, 1988
Do and In Vitro Dissolution Testing Atenolol (tablets) In Vivo Bioequivalence October 6, 1988
Do and In Vitro Dissolution Testing Clindamycin Hydrochloride (capsules) In May 31, 1988
Do Vivo Bioequivalence and In Vitro Dissolution Testing Diazepam In Vivo Bioequivalence Study
July 8, 1985
Do Dipyridamole Drug Products Bioavailability September 25, 1987
Do Disopyramide Phosphate (Capsules)
July 9, 1985
Do Doxepin Hydrochloride Drug Products In Vivo October 9, 1986
Do Bioequivalence Study Doxycycline Hyclate In Vivo Studies and In April 11, 1988
Do Vitro Dissolution Testing
[[Page 898]]
Erythromycin Capsules (Enteric Coated
September 21, 1988
Do Pellets) In Vivo Bioequivalence Study and In Vitro Dissolution Testing Fenoprofen (capsules and tablets) In Vivo February 3, 1988
Do Bioequivalence Study and In Vitro Dissolution Testing Haloperidol (tablets) In Vivo
April 30, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Hydroxyzine Pamoate (capsules) In Vivo September 28, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Isosorbide Dinitrate (chewable tablets, September 22, 1987
Do oral tablets, and sublingual tablets) In Vivo Bioequivalence Study and In Vitro Dissolution Testing Isosorbide Dinitrate (Controlled Release) November 6, 1985
Do In Vivo Bioavailability Studies Lorazepam (tablets) In Vivo Bioequivalence September 16, 1987
Do Study and In Vitro Dissolution Testing Megestrol Acetate (tablets) In Vivo
August 17, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Methylprednisolone (tablets) In Vivo
June 12, 1986
Do Bioequivalence Study and In Vitro Dissolution Testing Minoxidil (tablets)
June 12, 1986
Do Nafcillin Sodium (Capsules and Tablets) In September 10, 1987
Do Vivo Bioequivalence Study and In Vitro Dissolution Testing Norethindrone and Ethinyl Estradiol
March 18, 1988
Do (tablets) In Vivo Bioequivalence Study and In Vitro Dissolution Testing Norethindrone and Mestranol (tablets) In May 13, 1988
Do Vivo Bioequivalence Study and In Vitro Dissolution Testing Orphenadrine Citrate (tablets) In Vivo July 22, 1983
Do Bioequivalence Study and In Vitro Dissolution Testing Procainamide In Vivo Bioavailability
September 28, 1987
Do Studies Rifampin (capsules) In Vivo Bioequivalence September 8, 1988
Do Study and In Vitro Dissolution Testing Silver Sulfadiazine (cream)
May 7, 1987
Do Spironolactone In Vivo Single Dose Studies January 1, 1986
Do and In Vitro Dissolution Testing Sulfasalazine (tablets) In Vivo
October 8, 1987
Do Bioequivalence and In Vitro Dissolution Testing Sulindac (tablets) In Vivo Bioequivalence July 18, 1988
Do and In Vitro Dissolution Testing Theophylline (conventional dosage form) In September 1, 1984
Do Vivo Bioequivalence and In Vitro Dissolution Testing Timolol Maleate (tablets) In Vivo
August 9, 1988
Do Bioequivalence and In Vitro Dissolution Testing Tolmetin Sodium (tablets and capsules) In October 6, 1994
Do Vivo Bioequivalence and In Vitro Dissolution Testing Triazolam (tablets) In Vivo Bioequivalence December 24, 1992
Do and In Vitro Dissolution Testing Acetohexamide (tablets) In Vivo
August 1, 1988
Do Bioequivalence and In Vitro Dissolution Testing Allopurinol (tablets) In Vivo
July 15, 1985
Do Bioequivalence and In Vitro Dissolution Testing
[[Page 899]]
Amiloride Hydrochloride (tablets) In Vivo March 29, 1985
Do Bioequivalence and In Vitro Dissolution Testing Aminophylline (suppositories) In Vivo
July 5, 1983
Do Bioequivalence and In Vitro Dissolution Testing Amitriptyline Hydrochloride (tablets) In July 5, 1983
Do Vivo Bioequivalence and In Vitro Dissolution Testing Amoxicillin (capsules, tablets, and
July 10, 1988
Do suspensions) In Vivo Bioequivalence and In Vitro Dissolution Testing Baclofen (tablets) In Vivo Bioequivalence May 5, 1988
Do and In Vitro Dissolution Testing Cefadroxil (capsules, tablets, and
October 7, 1988
Do suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing Cephalexin (tablets and capsules) In Vivo March 19, 1987
Do Bioequivalence and In Vitro Dissolution Testing Cephradine (capsule and suspension) In Vivo September 10, 1986
Do Bioequivalence Studies Chlordiazepoxide and Chlordiazepoxide HCI July 5, 1983
Do Bioavailability and Dissolution Studies Chlorpropamide In Vivo Bioavailability July 5, 1983
Do Studies Chlorthalidone (tablets)
July 5, 1983
Do Clofibrate In Vivo Bioavailability Studies April 7, 1986
Do Clonidine Hydrochloride Drug Products In December 5, 1984
Do Vivo Bioequivalence Study and In Vitro Dissolution Testing Clorazepate In Vivo Bioequivalence Study February 17, 1987
Do and In Vitro Dissolution Testing Cyclobenzaprine Hydrochloride (tablets) In January 25, 1988
Do Vivo Bioequivalence Study and In Vitro Dissolution Testing Desipramine Hydrochloride (tablets) In Vivo September 22, 1987
Do Bioequivalence Studies Dicyclomine Hydrochloride Drug Products In August 10, 1984
Do Vivo Bioequivalence Dissolution Testing (General)
April 1, 1978
Do Estopipate Tablets In Vivo Bioequivalence August 26, 1992
Do Study and In Vitro Dissolution Testing Flurazepam Hydrochloride (capsules) In Vivo October 15, 1985
Do Bioequivalence Study and In Vitro Dissolution Testing Hydrochlorothiazide (tablets) In Vivo
September 28, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Hydroxyzine Hydrochloride (tablets)
March 4, 1986
Do (dissolution only) Indomethacin (capsules) In Vivo
January 27, 1988
Do Bioequivalence Study and In Vitro Dissolution Testing Isopropamide Iodide (tablets) In Vivo
May 12, 1982
Do Bioequivalence Study and In Vitro Dissolution Testing Loxapine Succinate (capsules) In Vivo
September 10, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Maprotiline Hydrochloride (tablets) In Vivo August 27, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Meclofenamate Sodium (capsules) In Vivo November 12, 1986
Do Bioequivalence Study and In Vitro Dissolution Testing Metaproterenol Sulfate (tablets) In Vivo March 18, 1986
Do Bioequivalence Study and In Vitro Dissolution Testing
[[Page 900]]
Metoclopramide Hydrochloride (tablets) In December 27, 1984
Do Vivo Bioequivalence Study and In Vitro Dissolution Testing Nalidixic Acid In Vivo Bioequivalence Study August 19, 1987
Do and In Vitro Dissolution Testing Nitrofurantion Macrocrystalline (capsules) January 10, 1986
Do In Vivo Bioequivalence Study and In Vitro Dissolution Testing Nitroglycerin Ointment In Vivo
December 17, 1986
Do Bioequivalence Studies Perphenazine (tablets) In Vivo
August 27, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Perphenazine/Amitriptyline (tablets) In August 27, 1987
Do Vivo Bioequivalence Study and In Vitro Dissolution Testing Phenylbutazone Oxyphenbutazone (capsules September 28, 1987
Do and tablets) In Vivo Bioequivalence Study and In Vitro Dissolution Testing Prazepam (capsules and tablets) In Vivo July 26, 1988
Do Bioequivalence Study and In Vitro Dissolution Testing Prednisone (tablets) (dissolution only) July 10, 1985
Do Probenecid Drug Products Bioavailability July 26, 1983
Do Study Propoxyphene Napsylate with Acetaminphen March 26, 1980
Do (tablets) Propranolol Hydrochloride (tablets) In Vivo August 1, 1984
Do Bioequivalence Study and In Vitro Dissolution Testing Propylthiouracil (tablets) In Vivo
August 13, 1986
Do Bioequivalence Study and In Vitro Dissolution Testing Quinidine Gluconate (tablets, controlled September 22, 1987
Do release) In Vivo Bioequivalence Study and In Vitro Dissolution Testing Ritodrine Hydrochloride (tablets) In Vivo August 27, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Sulfinpyrazone (Capsules and Tablets)
September 25, 1987
Do Sulfones (tablets) In Vivo Bioequivalence November 7, 1986
Do Study and In Vitro Dissolution Testing Temazepam In Vivo Bioequivalence Study and August 8, 1985
Do In Vitro Dissolution Testing Tolazamide (tablets) In Vivo Bioequivalence May 30, 1986
Do Study and In Vitro Dissolution Testing Tolbutamide (tablets) In Vivo
December 1, 1983
Do Bioequivalence Study and In Vitro Dissolution Testing Trimipramine Maleate (capsules) In Vivo August 18, 1987
Do Bioequivalence Study and In Vitro Dissolution Testing Verapamil Hydrochloride (tablets) In Vivo July 18, 1985
Do Bioequivalence Study and In Vitro Dissolution Testing Clinical Evaluation of Drugs for the
Clinical Treatment of Peripheral Vascular Disease Clinical Evaluation of Bronchodilator Drugs November 1, 1978
Clinical/Medical Topical Corticosteriod Class Labeling
Labeling
-
Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN)
[[Page 901]]
How to Obtain a Hard Copy of the Document Name of Document
Date of Issuance
Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or Regulatory Activity
Internet)
Level I Guidances
Draft Working Guide to Minimize Microbial 1998
Farmers and Food Packers
Lou Carson (HFS-3), Food and Drug Hazards for Fresh Fruits and Vegetables
Administration, 200 C. St. SW., Washington, DC 20204 or jsaltsman@bangate.fda.gov Notification of a Health Claim or Nutrient 1998
Regulated Industry
Office of Food Labeling (HFS-150), Food Content Claim Based on an Authoritative
and Drug Administration, 200 C. St. NW., Statement of a Scientific Body
Washington, DC 20204
-
Guidance Documents Issued by the Center for Veterinary Medicine (CVM)
How to Obtain a Hard Copy of the Document Name of Document
Date of Issuance
Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or Regulatory Activity
Internet)
Guidance for Industry: Use of Human
April 1998
FDA Regulated Industry
CVM Internet Home Page at http:// Chorionic Gonadotropin (HCG) as a Spawning
www.fda.gov/cvm, or from CVM's Aid for Fish
Communications Staff (HFV-12), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755, fax 301-594-1831 Guidance for Industry: GMP's For Medicated May 1998
Do
Do Feed Manufacturers Not Required to Register and Be Licensed With FDA VICH Draft Guidance for Industry: Stability July 1998
Do
Do Testing of New Animal Drug Substances and Products VICH Draft Guidance for Industry: Stability July 1998
Do
Do Testing for New Dosage Forms of New Animal Drugs: Draft Guidance VICH Draft Guidance for Industry: Stability July 1998
Do
Do Testing: Photostability Testing of New Animal Drug Substances and Products Guidance for Industry: Questions and
July 1998
Do
Do Answers; BSE Feed Regulations Guidance for Industry: Interpretation of On- August 1998
Do
Do Farm Feed Manufacturing and Mixing Operations; Draft Tolerances Established for Tetracyclines in August 11, 1998 (Updated) Do
Do Milk
Withdrawn
Points to Consider Guideline: Development 1993
Do of a Pharmacokinetic Guideline Enabling Flexible Labeling of Therapeutic Antimicrobials
-
Guidance Documents Issued by the Office of Regulatory Affairs
[[Page 902]]
How to Obtain a Hard Copy of the Document Name of Document
Date of Issuance
Grouped by Intended User or (Name and Address, Phone, FAX, E-mail or Regulatory Activity
Internet)
Compliance Policy Guide Medical Device August 27, 1998
FDA Staff Personnel
Division of Compliance Policy (HFC-230), Warning Letter Draft Pilot
Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet at www.fda.gov/ora/compliance‹INF›-- ref/dev‹INF›--pl.pdf Compliance Policy Guide 675.400 (CPG
November 13, 1998
Do
Do--Internet at www.fda.gov/ora/ 7126.24): REVISION Rendered Animal Feed
compliance‹INF›--ref/cpg/cpgvet/ Ingredients
cpg675.400.html Regulatory Procedures Manual: UPDATE/
June 1998
Do
Do--Internet at www.fda.gov/ora/ REVISION Subchapter/Seizure
compliance‹INF›--ref/rpm‹INF›--new2/ch6.html Regulatory Procedures Manual: UPDATE/
June 1998
Do
Do--Internet at www.fda.gov/ora/ REVISION Subchapter/Supervisory Charges
compliance‹INF›--ref/rpm‹INF›--new2/ch9chgs.html Regulatory Procedures Manual: NEW
July 1998
Do
Do--Internet at www.fda.gov/ora/ Subchapter/Civil Penalties--Electronic
compliance‹INF›--ref/ch6civpen.html Product Radiation Control Guide to Traceback of Fresh Fruits and August 1998
Do
Division of Emergency and Investigational Vegetables Implicated in Epidemiological
Operations (HFC-130), Office of Regional Investigations
Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276 Guide to Inspections of Computerized
August 1998
Do
Do--Internet at www.fda.gov/ora/inspect‹INF›-- Systems in the Food Processing Industry
ref/igf/iglist.html Import Alerts
Continuously
Do
Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or via Internet at www.fda.gov/ora/fiars/ora‹INF›-- import‹INF›--alerts.html Investigations Operations Manual-REVISION; July 1998
Do
Division of Emergency and Investigational Chapter 4--Sampling
Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276 or via internet at www.fda.gov/ora/inspect‹INF›--ref/iom/ iomtc.html Investigations Operations Manual-REVISION; July 1998
Do
Do Chapter 5--Establishment Inspection
Documents Not Included on Previously Published Lists
Compliance Policy Guide--DRAFT
January 5, 1998
Do
Division of Compliance Policy (HFC-230), Commercialization of In Vitro Diagnostic
Office of Enforcement, Food and Drug Devices (IVD's) Labeled for Research Use
Administration, 5600 Fishers Lane, Only or Investigational Use Only
Rockville, MD 301-827-0420 or via internet at www.fda.gov/cdrh/comp/ ivddrfg.html Compliance Policy Guide--DRAFT Distributor August 28, 1998
Do
Do or via internet at www.fda/gov/ora/ Medical Device Reporting
compliance‹INF›--ref/cpg‹INF›--mdr3.txt
Withdrawn
Compliance Policy Guide 530.400 (CPG
September 23, 1997
Do 7121.02) Vitamin Products for Human Use-- Low Potency Compliance Policy Guide 210.150 ( CPG 7134.09)Importation of Licensed Biological Products for Human Use
Corrections to July 6, 1998 Quarterly List
Guideline for the Monitoring of Clinical Revised November 1998 FDA Regulated Industry
Division of Compliance Policy (HFC-230), Investigators
Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 Computerized Systems Used in Clinical
June 18, 1997
Do
Do Trials Should be identified as a DRAFT
[[Page 903]]
ComplianceProgram 7348.808, Bioresearch Revised August 17, 1998 FDA Staff Personnel
Do--Internet http://www.fda.gov/ora/ Monitoring; Good Laboratory Practices
compliance‹INF›--ref/bimo/default.html (Nonclinical) Compliance Program 7348.810; Sponsors, Revised October 30, 1998 Do
Do--Internet http://www.fda.gov/ora/ Contract Research Organizations and
compliance‹INF›--ref/bimo/default.html Monitors Compliance Program 7348.811; Bioresearch Revised September 2, 1998 Do
Do--Internet http://www.fda.gov/ora/ Monitoring; Clinical Investigations
compliance‹INF›--ref/bimo/default.html The following documents are not available October 1, 1991
Do
Do via the internet: Food Laboratory Practice Program (Nonclinical Laboratories) 7348.808A; EPA Data Audit Inspections Compliance Program 7348.809; Bioresearch August 18, 1994 Monitoring; Institutional Review Board
-
Guidance Documents Issued by the Office of the Commissioner and the Office of Policy
How to Obtain a Hard Copy of the Name of Document
Date of Grouped by Intended User or Document (Name and Address, Phone, Issuance Regulatory Activity
FAX, E-mail or Internet)
Draft Guidance for Industry;
June 1998 FDA Regulated Industry Via Internet at http://www.fda.gov/ Exports and Imports under the FDA
opacom/fedregister/frexport.html Export Review and Enhancement Act of 1996 Policy & Guidance Handbook for FDA 1994
FDA Staff Personnel
National Technical Information Advisory Committees
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703- 487-4650 (Order No. PB94-158854)
Dated: December 28, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination.
[FR Doc. 99-155Filed1-5-99; 8:45 am]
BILLING CODE 4160-01-F
