Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutical Science; Notice of Meeting. (19NOV99)
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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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Mutual Recognition of Pharmaceutical Good Manufacturing Practices Annex; Public Meeting. (27OCT99)
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Guidance for Industry: Chemistry, Manufacturing and Control Changes to an Approved NADA or ANADA; Availability.  (01OCT99)
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Advisory Committee for Pharmaceutical Science; Notice of Meeting. (30AUG99)
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Draft Guidance for Industry on ANDA's: Blend Uniformity Analysis; Availability. (27AUG99)
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Advisory Committee for Pharmaceutical Science Site-specific Stability Sub-committee; Notice of Meeting. (26AUG99)
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Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.  (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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The 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 Draft Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products; Chemistry, Manufacturing, and Controls Documentation; Availability.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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The guidance

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: 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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Pharmacy Compounding Advisory Committee; Notice of Meeting. [TXT]  [PDF] (22APR99)
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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 on SUPAC09IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum; Availability. (26FEB99)
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Guidance . Click here for pdf

Draft Guidance for Industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System; Availability. (17FEB99)
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Pharmacy Compounding Advisory Committee Meeting; Amendment of Notice. (26JAN99)
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Draft Guidance for Industry on NDA's: Impurities in Drug Substances; Availability. (21JAN99)
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List of Bulk Drug Substances That May Be Used in Pharmacy Compounding. (07JAN99)
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Pharmacy Compounding Advisory Committee; Notice of Meeting. (06JAN99)
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Draft Guidance for Industry on SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum; 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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