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FEDERAL REGISTER NOTICES FOR DRAFT GUIDANCES - With closing comment dates in 1999.

NOTICES-DRAFT GUIDANCES

Vol. 64 (October 26, 1999): Docket No. 99D-4396, OC 99282. Draft Guidance for Industry on Financial Disclosure by Clinical Investigators; Availability. Pages 57640-57641 [FR Doc. 99-27840 ] [TXT] [PDF] [PRE-PUB] Written comments by December 27, 1999

Vol. 64 (October 21, 1999): Docket No. 99D-4328, CDER 9989. Draft Guidance for Industry on Developing Antimicrobial Drugs to Treat Catheter-Related Bloodstream Infections; Availability. Page 56799 [FR Doc. 99-27580] [TXT] [PDF] [PRE-PUB] Written comments by December 20, 1999

Vol. 64 (October 12, 1999): Docket No. 99D-4071, CVM 9956. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL18 Draft Guidance on ``Impurities: Residual Solvents;'' Availability; Request for Comments. Pages 55296-55297 [FR Doc. 99-26503] [TXT] [PDF] [PRE-PUB] Written comments by November 12, 1999

Vol. 64 (September 27, 1999): Docket No. 98D-0834, CDER 9946. Draft Guidance for Industry on Noncontraceptive Estrogen Class Labeling; Availability. Pages 52100-52101 [FR Doc. 99-24981] [TXT] [PDF] [PRE-PUB] Written comments by November 26, 1999

Vol. 64 (September 17, 1999): Docket No. 99D-2975, CVM 98154. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL6 Draft Guidance on `Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)-Phase I;'' Availability; Request for Comments. Pages 50519-50520 [FR Doc. 99-24208] [TXT] [PDF] [PRE-PUB] Written comments by October 18, 1999

Vol. 64 (September 8, 1999): Docket No. 97D-0433, CDER 9955. Draft Guidance for Industry on Average, Population, and Individual Approaches to Establishing Bioequivalence; Availability. Pages 48842-48843 [FR Doc. 99-23228] [TXT] [PDF] [PRE-PUB] written comments by November 8, 1999

Vol. 64 (September 8, 1999): Docket No. 99D-2726, CDRH 9947. Medical Devices; Draft Guidance on Labeling For Laboratory Tests; Availability. Pages 48843-48844 [FR Doc. 99-23229] [TXT] [PDF] [PRE-PUB] written comments by December 7, 1999

Vol. 64 (September 3, 1999): Docket No. 99D-2729, CDER 98161. Draft Guidance for Industry on BA and BE Studies for Orally Administered Drug Products -- General considerations;. Pages 48409-48410 [FR Doc. 99-23009 ] [TXT] [PDF] [PRE-PUB] Written comments by November 2, 1999

Vol. 64 (September 1, 1999): Docket No. 99D-2213, CDER 9824. 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. Page 47847 [FR Doc. 99-22801] [TXT] [PDF] [PRE-PUB] Written comments by November 30, 1999

Vol. 64 (September 1, 1999): Docket No. 99D-2873, CDRH 9949. Medical Devices; Draft Guidance on Evidence Models for the Least Burdensome Means to Market; Availability. Pages 47846-47847 [FR Doc. 99-22677] [TXT] [PDF] [PRE-PUB] Written comments by November 30, 1999

Vol. 64 (September 1, 1999): Docket No. 99D-2445, CDER 9945. Draft Guidance for Industry on Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements; Availability. Pages 47844-47845 [FR Doc. 99-22720] [TXT] [PDF] [PRE-PUB] Written comments by November 30, 1999

Vol. 64 (August 27, 1999): Docket No. 99D-2635, CDER 98197. Draft Guidance for Industry on ANDA's: Blend Uniformity Analysis; Availability. Page 46917 [FR Doc. 99-22317 ] [TXT] [PDF] [PRE-PUB] Written comments by October 26, 1999

Vol. 64 (August 25, 1999): Docket No. 99D-2638, OC 99226. Use of Medicated Feeds for Minor Species; Draft Compliance Policy Guide; Availability. Page 46400 [FR Doc. 99-21961] [TXT] [PDF] [PRE-PUB] Written comments by November 23, 1999

Vol. 64 (August 25, 1999): Docket No. 99D-2211, CDRH 9940. Medical Devices; Draft Guidance for Industry on the Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Availability. Pages 46399-46400 [FR Doc. 99-21962] [TXT] [PDF] [PRE-PUB] Written comments by November 23, 1999

Vol. 64 (August 18, 1999): Docket No. 99D-2636, CDER 9954. Draft Guidance for Industry on Levothyroxine Sodium; Availability. Page 44935 [FR Doc. 99-21353] [TXT] [PDF] [PRE-PUB] Written comments by October 18, 1999

Vol. 64 (August 17, 1999): Docket No. 99D-2405, CBER 9913. Draft ``Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act;'' Availability. Pages 44741-44742 [FR Doc. 99-21254] [TXT] [PDF] [PRE-PUB] Written comments by November 15, 1999

Vol. 64 (August 12, 1999): Docket No. 98D-0449, CDRH 9928. Draft Compliance Program Guidance Manual: Inspection of Medical Devices; Availability. Page 44024 [FR Doc. 99-20885] [TXT] [PDF] [PRE-PUB] Written comments by November 10, 1999

Vol. 64 (August 5, 1999): Docket No. 99D-2167, CDRH 9941. Medical Devices; Draft Guidance on the Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval; Availability. Pages 42700-42701 [FR Doc. 99-20089] [TXT] [PDF] [PRE-PUB] Written Comments by November 3, 1999

Vol. 64 (August 4, 1999): Docket No. 99D-2171, CDRH 9926. Medical Devices; Draft Guidance for the Accountability Analysis for Clinical Studies for Ophthalmic Devices; Availability. Pages 42391-42392 [FR Doc. 99-19976] [TXT] [PDF] [PRE-PUB] Written comments by November 2, 1999

Vol. 64 (August 3, 1999): Docket No. 99D-2152, CDRH 9943. Medical Devices; Device Use Safety: Incorporating Human Factors in Risk Management; Availability. Pages 42138-42139 [FR Doc. 99-19870] [TXT] [PDF] [PRE-PUB] Written comments by November 1, 1999

Vol. 64 (August 3, 1999): Docket No. 99D-2212, CDRH 9939. Medical Devices; Draft Guidance on Quality Systems Regulation Information for Various Premarket Submissions; Availability. Pages 42137-42138 [FR Doc. 99-19869] [TXT] [PDF] [PRE-PUB] Written comments by November 1, 1999

Vol. 64 (August 3, 1999): Docket No. 99D-2013, CBER 9741. Draft ``Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics''; Availability. Pages 42136-42137 [FR Doc. 99-19796] [TXT] [PDF] [PRE-PUB] Written comments by October 4, 1999

Vol. 64 (August 3, 1999): Docket No. 99D-2406, CVM 98157. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on VICH GL9 Good Clinical Practices; Request for Comments. Pages 42135-42136 [FR Doc. 99-19871] [TXT] [PDF] [PRE-PUB] Written comments by September 2, 1999

Vol. 64 (July 30, 1999): Docket No. 99D-2335, CDRH 9859. Medical Gloves; Draft Guidance Manual; Availability. Pages 41744-41745 [FR Doc. 99-19192] [TXT] [PDF] [PRE-PUB] Written comments by October 28, 1999

Vol. 64 (July 26, 1999): Docket No. 99D-2096, CBER 9845. Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations; Availability. Pages 40381-40382 [FR Doc. 99-18928] [TXT] [PDF] [PRE-PUB] Written comments by October 25, 1999

Vol. 64 (July 22, 1999): Docket No. 99D-2215, CVM 98158. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL10 Draft Guidance on ``Impurities in New Veterinary Drug Substances;'' Availability; Request for Comments. Pages 39516-39517 [FR Doc. 99-18697] [TXT] [PDF] [PRE-PUB] Written comments by August 23, 1999

Vol. 64 (July 22, 1999): Docket No. 99D-2249, CVM 98156. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on Stability Testing for Medicated Premixes; Availability; Request for Comments. Pages 39515-39516 [FR Doc. 99-18692] [TXT] [PDF] [PRE-PUB] Written comments by August 23, 1999

Vol. 64 (July 22, 1999): Docket No. 99D-2145, CVM 98159. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL11 Draft Guidance on Impurities in New Veterinary Medicinal Products; Availability; Request for Comments. Pages 39514-39515 [FR Doc. 99-18688] [TXT] [PDF] [PRE-PUB] Written comments by August 23, 1999

Vol. 64 (July 16, 1999): Docket No. 99D-2248, CVM 98155. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidances on Efficacy of Anthelmintics: General Recommendations (1B90), Efficacy of Anthelmintics: Specific Recommendations for Bovines (1B95), Efficacy of Anthelmintics: Specific Recommendations for Ovines (1B96), and Efficacy of Anthelmintics: Specific Recommendations for Caprines (1B97); Availability; Request for Comments. Pages 38445-38446 [FR Doc. 99-18166] [TXT] [PDF] [PRE-PUB] Written comments by August 26, 1999

Vol. 64 (July 15, 1999): Docket No. 98D-0077, CDER 98182. Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA); Availability. Pages 38201-38202 [FR Doc. 99-18031] [TXT] [PDF] [PRE-PUB] Written comments by September 13, 1999

Vol. 64 (June 28, 1999): Docket No. 99D-0529, CDER 98162. Draft Guidance for Industry on Changes to an Approved NDA or ANADA; Availability. Pages 34660-34661 [FR Doc. 99-16190] [TXT] [PDF] [PRE-PUB] Written comments by August 27, 1999

Vol. 64 (June 24, 1999): Docket No. 99D-1738, CDER 97192. Draft Guidance for Industry on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability. Page 33869 [FR Doc. 99-16140] [TXT] [PDF] [PRE-PUB] Written comments by September 22, 1999

The Draft Guidance [Not Yet Available]

Vol. 64 (June 24, 1999): Docket No. 99D-1718, CDER 9868. Draft Guidance for Industry on Monoclonal Antibodies Used as Reagents in Drug Manufacturing; Availability. Pages 33868-33869 [FR Doc. 99-16139] [TXT] [PDF] [PRE-PUB] Written comments by September 22, 1999

Vol. 64 (June 22, 1999): Docket No. 99D-1878, CBER 9914. `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 Testin. Pages 33309-33313 [FR Doc. 99-15754] [TXT] [PDF] [PRE-PUB] Written comments by August 23, 1999

Vol. 64 (June 10, 1999): Docket No. 99D-1149, CDER 97116. Draft Guidance for Industry on in Vivo Pharmacokinetics and Bioavailability Studies and in Vitro Dissolution Testing for Levothyroxine Sodium Tablets; Availability. Page 31280 [FR Doc. 99-14751] [TXT] [PDF] [PRE-PUB] Written comments by August 9, 1999

Vol. 64 (June 8, 1999): Docket No. 99D-1273, CDRH 97121. Medical Devices; Draft Guidance for FDA Staff on Civil Money Penalty Policy; Availability. Pages 30527-30528 [FR Doc. 99-14405] [TXT] [PDF] [PRE-PUB] Written comments by September 7, 1999

Vol. 64 (June 4, 1999): Docket No. 99D-1541, CDER 9863. Draft Guidance for Industry on Establishing Pregnancy Registries; Availability. Page 30041 [FR Doc. 99-14151] [TXT] [PDF] [PRE-PUB] Written comments by September 2, 1999

Vol. 64 (June 4, 1999): Docket No. 99D-1540, CDER 9861. Draft Guidance for Reviewers on Evaluation of Human Pregnancy Outcome Data; Availability. Pages 30040-30041 [FR Doc. 99-14149] [TXT] [PDF] [PRE-PUB] Written comments by September 2, 1999

Vol. 64 (June 2, 1999): Docket No. 99D-1454, CDER 98185. Draft Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products; Chemistry, Manufacturing, and Controls Documentation; Availability. Page 29657 [FR Doc. 99-13921] [TXT] [PDF] [NO PRE-PUB] Written comments by August 31, 1999

Vol. 64 (February 8, 1999): Docket No. 98D-1165, CDRH 98812. Draft Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Availability. Pages 6100-6101 [FR Doc. 99-2690] [TXT] [PDF] [PRE-PUB] Written comments by May 10, 1999

Vol. 64 (February 3, 1999): Docket No. 98D-1232, CDRH 98129. Points To Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft; Availability. Pages 5300-5301 [FR Doc. 99-2508] [TXT] [PDF] [PRE-PUB] Written comments by May 4, 1999