"Draft ``Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood
and Blood Products From Xenotransplantation Product Recipients and Their Contacts;'' Availability". (30DEC99)
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The Draft Guidance |
Withdrawal of Guidance Document on Selegiline Hydrochloride Tablets. (27DEC99)
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Guidance for Industry: Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal
Drugs Intended for Use in Food-Producing Animals (GFI 1B78); Availability (Corrects previous notice error). (24DEC99)
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Acupuncture Devices and Accessories; Revocation of Compliance Policy Guide 7124.11. (24DEC99)
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Draft Guidance for Industry on Disclosing Information Provided to Advisory Committees in Connection With Open Advisory
Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research, Beginning on January 1, 2000; Availability. (22DEC99)
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Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and
Dietary Supplements; Availability. (22DEC99)
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The Guidance |
Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing; Availability.
(21DEC99)
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Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of
Human Immunodeficiency Viruses Types 1 and 2; Availability. (20DEC99)
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Guidance for Industry: Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal
Drugs Intended for Use in Food-Producing Animals (GFI 1B78); Availability. (17DEC99)
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Medical Devices; Draft Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery;
Availability. (16DEC99)
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The Draft Guidance |
Draft Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #3; Availability. (08DEC99)
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Draft Guidance for Industry on Applications Covered by Section 505(b)(2); Availability. (08DEC99)
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Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data
Analysis, and Impact on Dosing and Labeling; Availability". (07DEC99)
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Guidance for Industry on ANDA's: Impurities in Drug Substances; Availability. (03DEC99)
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Draft Guidance for Industry on Labeling of Over-the-Counter Human Drug Products Using a Column Format; Availability,
(01DEC99)
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Draft Guidance |
Guidance for Industry on Drug Master Files for Bulk Antibiotic Drug Substances; Availability. (29NOV99)
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The Guidance |
Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob
Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products; Availability. (23NOV99)
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Guidance for Industry on Changes to an Approved NDA or ANDA; Availability. (23NOV99)
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The Guidance |
Medical Devices; Draft Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for
Medical Gloves; Availability. (16NOV99)
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Draft Guidance |
Semiannual Guidance Agenda. (15NOV99)
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Draft Guidances for Industry on Food-Contact Substance Notification System; Availability. (12NOV99)
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Draft Guidance |
Draft ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral
Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors;'' Availability. (03NOV99)
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Enforcement Policy: Electronic Records; Electronic Signatures_Compliance Policy Guide; Guidance for FDA Personnel. (30JUL99)
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Home Uterine Activity Monitors Guidance; Availability. (30JUL99)
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The Guidance |
Medical Gloves; Draft Guidance Manual; Availability. (30JUL99)
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The Draft Guidance |
Draft ``Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations;''
Availability. (26JUL99)
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The Draft Guidance |
Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures_Compliance Policy Guide; Guidance for FDA
Personnel. (21JUL99)
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Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment
of Osteoarthritis (OA); Availability. (15JUL99)
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The Draft Guidance |
Review of Guidances for Industry on the Development of Generic Drug Products; Development and Use of FDA Guidance Documents;
Request for Comments. (08JUL99)
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Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and
Controls Documentation; Availability. (07JUL99)
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Draft Guidance for Industry on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action;
Availability. (24JUN99)
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Draft Guidance for Industry on Monoclonal Antibodies Used as Reagents in Drug Manufacturing; Availability. (24JUN99)
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Prepublication documentThe Guidance |
Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition
of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for
Antibody to HCV (Anti-HCV); Availability (22JUN99)
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Prepublication documentThe Guidance |
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration (10JUN99)
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Medical Devices; Draft Guidance for FDA Staff on Civil Money Penalty Policy; Availability. (08JUN99)
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Draft Guidance for Industry on Establishing Pregnancy Registries; Availability. (04JUN99)
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Draft Guidance for Reviewers on Evaluation of Human Pregnancy Outcome Data; Availability. (04JUN99)
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The Draft Guidance |
Docket No. 99D-1454, CDER98185. Draft Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray Drug
Products; Chemistry, Manufacturing, and Controls Documentation; Availability. (02JUN99)
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Medical Devices; Draft Guidance on Quality Systems Inspections Technique; Availability. (28MAY99) Click here for txt or pdf
The Guidance |
Draft Guidance for Industry: For Platelet Testing and Evaluation of Platelet Substitute Products; Availability. (21MAY99) Click
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Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use;
Availability. (21MAY99) Click here for txt or pdf The Guidance |
Year 2000 (Y2K) Computer Compliance Guide; Guidance for FDA Personnel," OC99111, DOCKET 99D-1089 (14MAY99) Click here for
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Final Guidance on FDA Approval of New Animal Drugs for Minor Uses and for Minor Species; Availability(14MAY99) Click here for
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Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for
Human Blood and Blood components Intended for Transfusion of for further manufacture and for the completion of the form FDA356h, Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use;
Availability. (10MAY99) Click here for txt or pdf The Guidance |
Guidance for Industry: Computerized Systems Used in Clinical Trials; Availability. (10MAY99) Click here for txt or pdf The Guidance |
Immunotoxicity Testing Guidance; Availability. (06MAY99) Click here for txt or pdf The Guidance |
Immunotoxicity Testing Guidance; Availability. (06MAY99) Click here for txt or pdf The Guidance |
Draft Guidance for Industry on Placing the Therapeutic Equivalence Code on Prescription Drug Labels and Labeling; Availability;
Reopening of Comment Period. [TXT] [PDF] (22APR99)
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Draft Guidance for Industry on IND's for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived
Products; Chemistry, Manufacturing, and Controls Content and Format; Availability. [TXT] [PDF] (21APR99). Click here for txt or pdf
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pdf |
Draft Guidance for Industry on Formal Dispute Resolution; Appeals above the Division Level; Availability; Correction. Click here
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Draft Guidance for Industry on Formal Meetings With Sponsors and Applicants for PDUFA Products; Availability; Correction.Click
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pdf (12APR99) |
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1; Availability
(19MAR99)
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Guidance . Click here for
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Draft Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #2;
Availability. (19MAR99)
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Guidance .Click here for
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Draft Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products;
Availability. (19MAR99)
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Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
Establishment Description Information for a Biological in Vitro Diagnostic Product; Availability. (08MAR99)
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Points To Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft;
Availability. (03FEB99)
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Draft Guidance. Click here for pdf |
Guidance for Industry on FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological
Products; Availability. (03FEB99)
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Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical
Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community; Availability. (03FEB99)
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