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Contents (.PDF)              Federal Register

Contents (.TXT)              Vol. 64, No.31

Wednesday, February 17, 1999

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Food and DrugAdministration
PROPOSED RULES
Docket No. 98N-1038, CFSAN98217. Irradiation in the Production, Processing, and Handling of Food.  Pages 7834-7837 [FR Doc. 99-3714] [TXT] [PDF]  Written comments by May 18, 1999.
NOTICES
OC9937. Current Issues in Human Subject Protection; Public Meeting.  Page 7896 [FR Doc. 99-3775]  [TXT] [PDF]

Docket No. 96D-0067, CDER98183. Guidance for Industry on Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA); Availability.  Pages 7898-7899 [FR Doc. 99-3776] [TXT] [PDF]

The Guidance
Docket No. 98D-0007, CBER9823. 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. Pages 7896-7897 [FR Doc. 99-3715] [TXT] [PDF]
The Guidance
Docket No. 99D-0121, CDER97188. Draft Guidance for Industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active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. Pages 7897-7898 [FR Doc. 99-3777] [TXT] [PDF]  Written comments by April 19, 1999.
The Guidance