International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New
Drug Substances and New Drug Products: Chemical Substances. (29DEC00)
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Cooperative Arrangement Between the United States Food and Drug Administration and Therapeutic Goods Administration,
Republic of Australia Regarding the Exchange of Information on Current Good Manufacturing Practice Inspections of Human Pharmaceutical Facilities. (29DEC00)
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Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practices and Related
Regulations for Blood and Blood Components. (12DEC00)
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Supporting Statement |
Guidance for Industry and for FDA Employees on Import Alert G6 T1# K660966, Detention Without Physical Examination of
Active Pharmaceutical Ingredients That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet the Requirements for the Labeling Exemptions in 21 CFR 201.122; Availability. (04DEC00)
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The Guidance
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Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients
Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback). (16NOV00)
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Biological Products: Reporting of Biological Product Deviations in Manufacturing; Correction. (09NOV00)
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Biological Products: Reporting of Biological Product Deviations in Manufacturing. (07NOV00)
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Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.
(03NOV00)
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Advisory Committee for Pharmaceutical Science; Notice of Meeting. (17OCT00)
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Guidance for Industry,
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Draft Guidance for Industry,
BA and BE Studies for Orally Administered Drug Products-General Considerations
Guidance for Industry, Average, Population, and Individual Approaches to Establishing Bioequivalence
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practices
and Related Regulations for Blood and Blood Components. (06OCT00)
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Draft Guidance for Industry on Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls
Documentation; Availability. (30AUG00)
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The Draft Guidance
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International Conference on Harmonisation; Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical
Ingredients; Availability. (01AUG00)
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The Draft Guidance |
Request for Nominations for Working Groups Under the Nonclinical Studies Subcommittee of the Advisory Committee for
Pharmaceutical Science. (26JUL00)
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International Conference on Harmonisation; Draft Revised Guidance on Impurities in New Drug Substances. (20JUL00)
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International Conference on Harmonisation; Draft Revised Guidance on Impurities in New Drug Products. (19JUL00)
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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and
Related Regulations for Blood and Blood Components. (06JUL00)
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Pharmacy Compounding Advisory Committee; Notice of Meeting. (29JUN00)
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International Conference on Harmonisation; Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and
Products. (21APR00)
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Orally Inhaled and Nasal Drug Products Subcommittee of the Advisory Committee for Pharmaceutical Science; Notice of
Meeting. (22MAR00)
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Guidance for Industry on NDAs: Impurities in Drug Substances (25FEB00)
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The Guidance |
Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutical Science; Notice of Meeting. (10FEB00)
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Draft Guidance for Industry on IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls
Information; Availability. (04FEB00)
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The Draft Guidance |
New Drug Applications; Drug Master Files. (12JAN00)
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