"CLIA Program; Transfer of Clinical Laboratory Complexity Categorization Responsibility". (30DEC99)
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"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The Draft Guidance |
Subcommittee of the Biological Response Modifiers Advisory Committee; Notice of Meeting. (27DEC99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Blood Establishment Registration
and Product Listing, Form FDA 2830. (20DEC99)
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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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The Guidance |
Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data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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The Draft Guidance |
Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports. (01DEC99)
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Implementation of Universal Leukoreduction; Public Workshop. (30NOV99)
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Guidance for Industry on Drug Master Files for Bulk Antibiotic Drug Substances; Availability. (29NOV99)
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The Guidance |
Guidance for Industry on In Vivo Drug Metabolism/Drug Interaction Studies_Study Design, Data Analysis, and
Recommendations for Dosing and Labeling; Availability. (24NOV99)
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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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The Guidance |
Guidance for Industry on Changes to an Approved NDA or ANDA; Availability. (23NOV99)
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The Guidance |
Blood Donor Suitability Workshop; Public Workshop. (23NOV99)
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Workshop on Implementation of Nucleic Acid Testing; Public Workshop. (23NOV99)
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``Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in
Electronic Format-Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]''; Availability.
(12NOV99)
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The Guidance |
Blood Safety Initiative: Extension of Comment Period on Proposed Rules and Announcement of Public Meeting. (09NOV99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing
Practices for Blood and Blood Components; Notification of Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV Infection. (04NOV99)
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Agency Emergency Processing Request Under OMB Review; Guidance for Industry; Changes to an Approved NDA or ANDA.
(03NOV99)
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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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The Draft Guidance |
Mutual Recognition of Pharmaceutical Good Manufacturing Practices Annex; Public Meeting. (27OCT99)
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Draft Guidance for Industry on Financial Disclosure by Clinical Investigators; Availability. (26OCT99)
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The Draft Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; Application to Market a New Drug, Biologic, or an
Antibiotic Drug for Human Use_Form FDA 356h. (21OCT99)
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Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License;
Elimination of Establishment License and Product License. (20OCT99)
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Vaccines and Related Biological Products Advisory Committee; Notice of Meeting. (19OCT99)
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Prepublication document |
Jay Marcus; Proposal to Debar; Opportunity for a Hearing. (15OCT99)
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Guidance for Industry on Qualifying for Pediatric Exclusivity; Availability; Revised. (08OCT99)
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The Guidance |
"Industry Training on Electronic Records; Electronic Signatures; Satellite Conference; Public Meeting". (08OCT99)
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Agency Information Collection Activities; Announcement of OMB Approval; Investigational New Drug (IND) Regulations. (07OCT99)
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Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; Dissemination of Information on Unapproved/New Uses for
Marketed Drugs, Biologics, and Devices. (07OCT99)
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Supporting Statement |
New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently
Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted. (05OCT99)
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OC 9817. Human Drugs and Biologics; Determination That Informed Consent Is NOT Feasible or Is Contrary to the Best
Interests of Recipients; Revocation of 1990 Interim Final Rule; Establishment of New Interim Final Rule. (05OCT99)
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Prepublication document |
Suitability Determination for Donors of Human
Cellular and Tissue-Based Products. (30SEP99)
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International Conference on Harmonisation; Choice of Control Group in Clinical Trials. (24SEP99)
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Workshop on Standards for Inactivation and Clearance of Infectious Agents in the Manufacture of Plasma Derivatives from Nonhuman
Sources for Human Injectable Use; Public Workshop. (23SEP99)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; MedWatch: The FDA Medical Products
Reporting Program.
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Prepublication document |
Development of Guidance Documents for Medical Devices Regulated by the Center for Biologics Evaluation and Research; Stakeholders
Input Under FDA Modernization Act of 1997; Public Meeting and Teleconference. (17SEP99)
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Guidance for Industry on Submission of Abbreviated Reports and Synopses in Support of Marketing Applications; Availability.
(13SEP99)
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The Guidance |
Draft Guidance for Industry on Average, Population, and Individual Approaches to Establishing Bioequivalence; Availability.
(08SEP99)
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Prepublication document
The Draft Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product
Listing, Form FDA 2830. (03SEP99)
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Prepublication document |
Delegations of Authority and Organization; Redelegation to Officials Within the Center for Biologics Evaluation and Research.
(01SEP99)
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Draft``Guidance for Industry: Revised Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared
Bloodborne Pathogen Assays to Test Donors;'' Availability. (01SEP99)
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The Draft Guidance |
Blood Products Advisory Committee; Notice of Meeting. (30AUG99)
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Prepublication document |
Guidance for Industry on Possible Dioxin/PCB Contamination in Drugs and Biological Products; Availability. (27AUG99)
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The Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Draft Guidance for Industry on Formal
Meetings with Sponsors and Applicants for PDUFA Products. (26AUG99)
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Workshop on Bacterial Contamination of Platelets; Public Workshop. (26AUG99)
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Vaccines and Related Biological Products Advisory Committee; Notice of Meeting. (26AUG99)
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Prepublication document |
General Requirements for Blood, Blood Components, and Blood Derivatives;Notification of Deferred Donors. (19AUG99)
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Prepublication document |
Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents. (19AUG99)
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Prepublication document |
Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma. (19AUG99)
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Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Companion Document to Direct Final Rule.
(19AUG99)
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Plasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification. (19AUG99)
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International Conference on Harmonisation:Guidance on Specifications:Test Procedures and Acceptance Criteria for
Biotechnological/biological Products. (18AUG99)
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Prepublication document |
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. (17AUG99)
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The Guidance |
Evaluation and Processing of Post Donation Information Reports; Compliance Policy Guide; Guidance for FDA Personnel;
Availability; Comment Request. (17AUG99)
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Prepublication document
The Guidance |
Draft ``Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act;''
Availability. (17AUG99)
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Prepublication document |
Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Cell Substitutes; Public Workshop on Septenber 27 and
28, 1999. (12AUG99)
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Prepublication document |
Guidance For Industry on Consumer-Directed Broadcast Advertisements; Availability. (09AUG99)
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The Draft Guidance with Questions & Answers |
Changes to an Approved NDA or ANDA; Proposed Rule and Draft Companion Guidance (05AUG99)
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Prepublication document |
Update of Guidance Documents at the Food and Drug Administration. (04AUG99)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Blood
and Blood Components; Notification of Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV Infection. (03AUG99)
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Agency Information Collection Activities; Announcement of OMB Approval; Survey of Licensed Biologics Manufacturers and Registered
Blood Establishments for Year 2000 Compliance. (03AUG99)
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Prepublication document
Supporting Statement |
Draft ``Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics''; Availability. (03AUG99)
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Prepublication document
The Draft Guidance |
International Workshop on the Standardization of Whole Blood Coagulation Devices.(02AUG99)
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Prepublication document |
Enforcement Policy: Electronic Records; Electronic Signatures_Compliance Policy Guide; Guidance for FDA Personnel. (30JUL99)
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Prepublication document |
Draft ``Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations;''
Availability. (26JUL99)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Dissemination of Information on
Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (23JUL99)
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Prepublication document |
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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Prepublication document |
Pilot Training and Research Program; Demonstration Project; Studies in Clinical Pharmacology and New Drug Review Technologies;
Availability of Cooperative Agreements; Request for Applications. (09JUL99)
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Prepublication document |
Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and
Controls Documentation; Availability. (07JUL99)
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Biological Response Modifiers Advisory Committee; Notice of Meeting (29JUN99)
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Prepublication document |
Supplements and Other Changes to an Approved Application. (28JUN99)
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Prepublication document |
Blood Donor Suitability Workshop: Donor History of Hepatitis (25JUN99)
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Prepublication document |
International Conference on Harmonization; Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Non-rodent
Toxicity Testing); Availability (25JUN99)
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Prepublication document |
Agency Information Collection Activities; Announcement of OMB Approval; Adverse Experience Reporting for Licensed Biological
Products, and General Records (25JUN99)
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Prepublication document
Supporting statement |
Draft Guidance for Industry on Monoclonal Antibodies Used as Reagents in Drug Manufacturing; Availability. (24JUN99)
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Prepublication document
The Guidance |
The FDA Review Process for New Product Applications: An Interactive Workshop.(23JUN99)
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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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The Guidance |
OC99117. Active Pharmaceutical Ingredient Workshop. (28MAY99)
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Agency Information Collection Activities; Agency Emergency Processing Request under OMB Review; Survey of Licensed Biologics
Manufacturers and Registered Blood Establishments for Year 2000 Compliance. (25MAY99) Click here for txt or pdf |
Blood Products Advisory Committee; Notice of Meeting. (21MAY99) Click here for txt or pdf |
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting. (21MAY99) Click here for txt or pdf |
Draft Civil Money Penalty Reduction Policy for Small Entities. (18MAY99) Click here for txt or pdf |
Biological Response Modifiers Advisory Committee; Notice of Meeting. (18MAY99) Click here for txt or pdf |
Biological Response Modifiers Advisory Committee; Notice of Meeting. (18MAY99) Click here for txt or pdf |
Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Confirmation of Effective
Date. (17MAY99) Click here for txt or pdf |
Immunotoxicity Testing Guidance; Availability. (06MAY99) 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 |
Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human). (14MAY99)
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Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Companion
Document to Direct Final Rule. (14MAY99) Click here for txt or pdf |
Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establisment 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 |
Assessment of Preclinical Reproductive Toxicity Data; Public Meeting. (04MAY99) Click here for txt or pdf |
Iatric Corp.; Revocation of U.S. License No. 0416. [TXT] [PDF] (26APR99)
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Food and Drug Administration Modernization Act of 1997; List of Documents Issued by the Food and Drug Administration That Apply
to Medical Devices Regulated by the Center for Biologics Evaluation and Research. [TXT] [PDF] (26APR99)
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Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment
Description Information for an Allergenic Extract or Allergen Patch Test'; Availability. [TXT] [PDF] (23APR99)
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Bestblood, Ltd.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 1116. [TXT] [PDF] (15APR99)
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txt or pdf |
Guidance for Industry: "Public Health Issues posed by the Use of Nonhuman Primate Xenografts in Humans;"
Availability. Click here for txt or pdf (06APR99)
Guidance Document. Click here for pdf |
Human Tissue Seminar (17MAR99)
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Site Specific Stability Data for Drug and Biologic Applications; Public Meeting; Request for Comment.
(16MAR99)
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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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Guidance . Click here for
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Agency Information Collection Activities: Proposed Collection; Comment Request; Dissemination of
Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (04MAR99)
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Agency Information Collection Activities; Announcement of OMB Approval; Establishment Registration and
Listing for Manufacturers of Human Cellular and Tissue-Based Products. (02MAR99)
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Supporting Statement. Click here for pdf |
Agency Information Collection Activities; Announcement of OMB Approval; Regulations Requiring Manufacturers
to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients. (26FEB99)
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Supporting Statement. Click here for pdf |
Cumulative List of Orphan Drug and Biological Designations. (26FEB99)
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OC9939.Blood Products Advisory Committee; Notice of Meeting. (22FEB99)
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Vaccines and Related Biological Products Advisory Committee; Notice of Meeting. (19FEB99)
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Guidance for Industry on Clinical Development Programs for Drugs, Devices, and Biological Products for the
Treatment of Rheumatoid Arthritis (RA); Availability. (17FEB99)
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Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment
Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products; Availability. (17FEB99)
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Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability; Extension of
Comment Period. (16FEB99)
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Guidance for Industry on FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological
Products; Availability. (03FEB99)
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The Guidance.Click here for pdf |
Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Current Good
Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections from Donors with Repeatedly Reactive Screening Test 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. (27JAN99)
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Supporting Statement. Click here for pdf |
Pilot Program for Gamma Irradiated Blood and Blood Components and Draft "Guidance for Industry: Gamma
Irradiation of Blood and Blood Components: A Pilot Program for Licensing;" Availability. (27JAN99)
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Draft Guidance. Click here for pdf |
Agency Information Collection Activities; Announcement of OMB Approval; Dissemination of Information on
Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (19JAN99)
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Supporting Statement. Click here for pdf |
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting. (13JAN99)
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txt or pdf |
Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability; Reopening of
Comment Period. (05JAN99
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Draft Guidance for Industry on Bioanalytical Methods Validation for Human Studies; Availability. (05JAN99)
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|
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
Establishment Description Information for a Vaccine or Related Product; Availability. (05JAN99)
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The draft guidance. Click here for pdf |
