Bioavailability and Bioequivalence Requirements; Abbreviated Applications; Final Rule. (19DEC02)
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Bavarian Red Cross; Revocation of U.S. License No. 1002. (03DEC02)
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Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases
of Known or Suspected West Nile Virus Infection.
(29NOV02)
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Guidance |
Blood Products Advisory Committee; Notice of Meeting. (27NOV02)
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Agency Collection Information Activities; Submission for OMB Review; Comment Request; Blood Establishment Registration and
Product Listing, Form FDA 2830. (19NOV02)
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Vaccines and Related Biological Products Advisory Committee; Notice of Meeting. (15NOV02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; New Drug and Biological Drug Products;
Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible. (13NOV02)
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Guidance for Industry on Antiretroviral Drugs Using Plasma Human Immunodeficiency Virus Ribonucleic Acid
Measurements--Clinical Considerations for Accelerated and Traditional Approval; Availability. (01NOV02)
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The Guidance--Word
The Guidance--PDF |
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting. (30OCT02)
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Development of Donor Screening Assays for West Nile Virus; Public Workshop. (24OCT02)
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Draft Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components;
Availability. (18OCT02)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practices
and Related Regulations for Blood and Blood Components; and Lookback Requirements. (08OCT02)
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Biological Response Modifiers Advisory Committee; Amendment of Notice. Changes location of meeting from NIH to
Gaithersburg, MD and adds a discussion topic.
(08OCT02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed
Biological Products; and General Records.
(04OCT02)
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Biological Response Modifiers Advisory Committee; Notice of Meeting. (27SEP02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Dissemination of Information on
Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (16SEP02)
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Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and
Animals; Availability. (12SEP02)
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The Draft Guidance |
Draft Guidance for Industry, Electronic Records; Electronic Signatures, Maintenance of Electronic Records; Availability.
(05SEP02)
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The Draft Guidance |
Agency Information Collection Activities; Announcement of OMB Approval; General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling Forms FDA 356h and 2567; and Revocation and Suspension. (05SEP02)
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Supporting Statement |
Science and Regulation of Biological Products: From a Rich History to a Challenging Future; Public Symposium; Amendment.
(04SEP02)
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Blood Products Advisory Committee; Notice of Meeting. (27AUG02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Regulations Requiring Manufacturers
to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients. (13AUG02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and
Product Listing, Form FDA 2830. (02AUG02)
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Beauregard Plasma, Inc., Jackson Plasma, Inc., Baton Rouge Plasma, Inc., and Claiborne Plasma, Inc.; Revocation of U.S.
License Nos. 1030, 1031, 1032, and 1033.
(26JUL02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Regulations.
(22JUL02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and
Related Regulations for Blood and Blood Components; and Lookback Requirements. (22JUL02)
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Safety and Efficacy of Methods for Reducing Pathogens in Cellular Blood Products Used in Transfusion; Public Workshop.
(17JUL02)
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Science and Regulation of Biological Products: From a Rich History to a Challenging Future; Public Symposium. (17JUL02)
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Evidence Based Assisted Reproductive Technologies (ART); Public Workshop. (12JUL02)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Telephone Questionnaire Administration to
Control Subjects Recruited into FDA Lyme Vaccine Safety Study, A Case-Control Study of HLA Type and T-Cell Reactivity to Recombinant Outer Surface Protein A and Human Leukocyte Function-Associated Antigen-1. (27JUN02)
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Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob disease
(CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability.
(25JUN02)
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Investigational New Drugs: Export Requirements for Unapproved New Drug Products. (19JUN02)
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International Conference on Harmonisation; Draft Guidance on Q1E Evaluation of Stability Data; Availability. (14JUN02)
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The Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; General Licensing Provisions:
Biologics License Application, Changes to an Approved Application, Labeling Forms FDA 356h and 2567; and Revocation and Suspension.
(07JUN02)
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Cumulative List of Orphan Drug and Biological Designations. (07JUN02)
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The List (180 pages) |
Draft Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Availability.
(04JUN02)
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The Draft Guidance |
New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy
Studies Are Not Ethical or Feasible.
(31MAY02)
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Blood Products Advisory Committee; Notice of Meeting. (30MAY02)
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Guidance for Industry on Carcinogenicity Study Protocol Submissions; Availability. (23MAY02)
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The Guidance |
Compliance Policy Guidance for FDA Staff and Industry on Blood Donor Classification Statement, Paid or Volunteer Donor;
Availability. (17MAY02)
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Guidance for Industry on Special Protocol Assessment; Availability. (17MAY02)
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Combination Products Containing Live Cellular Components; Public Hearing. (15MAY02)
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Bavarian Red Cross; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 1002. (09MAY02)
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Comparability Studies for Human Plasma-Derived Therapeutics; Public Workshop. (07MAY02)
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Vaccines and Related Biological Products Advisory Committee; Notice of Meeting. (02MAY02)
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Agency Information Collection Activities; Announcement of OMB Approval; Application for FDA Approval to Market a New Drug.
(30APR02)
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Supporting Statement |
Craig H. Petrik; Debarment Order.
(30APR02)
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Obtaining Timely Pediatric Studies of and Adequate Pediatric Labeling for Human Drugs and Biologics. (24APR02)
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Draft Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered
Questionnaires; Availability. (22APR02)
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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. (16APR02)
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Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to
Test Blood, Blood Components, and Source Plasma Donations; Availability. (11APR02)
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The Draft Guidance |
Drug Information Association and Food and Drug Administration on the Fourth Project Management Workshop: Effective
Agency/Industry Interactions to Expedite Drug Development; Public Workshop. (10APR02)
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Draft "Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and
Blood Components for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV;" Availability.
(09APR02)
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The Draft Guidance |
Draft Guidance for Industry on IND Exemptions for Studies of Lawfully Marketed Cancer Drug or Biological Products;
Availability. (09APR02)
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The Draft Guidance |
Anthrax Vaccines; Efficacy Testing and Surrogate Markers of Immunity; Public Workshop. (09APR02)
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Draft Guidance for Industry on Exposure-Response Relationships: Study Design, Data Analysis, and Regulatory Applications;
Availability. (02APR02)
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The Draft Guidance |
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational New Drug
Applications IINDs); Availability.
(29MAR02)
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The Guidance |
Drug Manufacturing Inspections; Public Workshops. (29MAR02)
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Agency Information Collection Activities; Announcement of OMB Approval; Foreign Establishment Registration and Listing.
(26MAR02)
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Supporting Statement |
Draft Guidance for Industry on Electronic Records; Electronic Signatures, Time Stamps; Availability. (20MAR02)
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The Draft Guidance |
Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions;
Availability. (18MAR02)
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The Guidance |
Anticaries Drug Products for Over-the-Counter Human Use; Use of Intraoral Appliance Models for Compliance with Biological
Testing Requirements; Request for Information and Comments; Reopening of Comment Period. (15MAR02)
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Ashford Blood Bank, Inc.; Revocation of U.S. License No. 0740-001. (14MAR02)
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Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation;"
Availability. (13MAR02)
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Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews.
(06MAR02)
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Blood Products Advisory Committee; Notice of Meeting. (28FEB02)
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Vaccines and Related Biological Products Advisory Committee; Notice of Meeting. (22FEB02)
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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 Intimate Contacts. (11FEB02)
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The Draft Guidance |
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics
License Application, Changes to an Approved Application, Labeling Forms FDA 356h and 2567; and Revocation and Suspension.
(08FEB02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Financial Disclosure by Clinical
Investigators. (08FEB02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Revised Draft Guidance for Industry
on Developing Medical Imaging Drugs and Biologics. (07FEB02)
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Best Practices for Reducing Transfusion Errors; Public Workshop. (01FEB02)
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CBER 200146. Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled Plasma Donors to Adequately and
Appropriately Reduce the Risk of Transmission of HIV-1 and HCV. (31JAN02)
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The Draft Guidance |
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting. (23JAN02)
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Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products;" Availability. (16JAN02)
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Guidance for Industry: Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of
Possible Exposure to Anthrax; Availability.
(14JAN02)
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Beauregard Plasma, Inc., Jackson Plasma, Inc., Baton Rouge Plasma, Inc., and Claiborne Plasma, Inc.; Opportunity for
Hearing on a Proposal to Revoke U.S. License Nos. 1030, 1031, 1032, and 1033. (09JAN02)
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Joint Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee and the Blood Products
Advisory Committee; Notice of Meeting.
(03JAN02)
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