FDA

Food and Drug Administration

Welcome to 1999

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Contents (.PDF)              Federal Register

Contents (.TXT)              Vol. 64, No. 2

Tuesday, January 5, 1999

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Food and Drug Administration
RULES
Direct Food Substances Affirmed as Generally Recognized as Safe; Magnesium Hydroxide; Technical Amendment. Pages 404-405 [FR Doc. 99-28] CFSAN 98226, Docket No. 78N-0281 [txt][pdf]

Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act. Pages 396-404 [FR Doc. 99-140] CDER 9824, Docket No. 98N-0720 [txt][pdf]

PROPOSED RULES

Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Companion Document to Direct Final Rule. Pages 448-457 [FR Doc. 99-141]   CDER 9875, Docket No.98N-0720 [txt][pdf]  Comments due by March22,1999

Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability; Reopening of Comment Period. Page  457 [FR Doc. 99-72] CBER 9865, Docket No. 98D-0785 [txt] [pdf]Comments due by February29,1999

NOTICES

Agency Information Collection Activities; Announcement of OMB Approval; Recordkeeping for Electronic Products, Specific Product Requirements. Page 516 [FR Doc. 99-71] OC 98432, Docket No. 98N-0213 [txt][pdf]

    SUPPORTING STATEMENT FOR Reporting and Recordkeeping For Electronic Products

Draft Guidance for Industry on ANDA's: Impurities in Drug Products; Availability. Page 516 [FR Doc. 99-31 CDER98104, Docket No. 98D-1168 [txt][pdf]Comments due by May 5,1999

The draft guidance Draft Guidance for Industry on Bioanalytical Methods Validation for Human Studies; Availability. Page  517 [FR Doc. 99-69] CDER98112, Docket No. 98d-1195 [txt][pdf]Comments due by March 8,1999 The draft guidance Food Additive Petition Expedited Review - Guidance for Industry and Center for Food Safety and Applied Nutrition Staff; Availability. Pages 517-518 [FR Doc. 99-70] CFSAN98210, Docket No. 98D-1164 [txt][pdf] The draft guidance Draft Guidance for Industry on SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum; Availability. Pages 518 [FR Doc. 99-29] CDER97146, Docket No. 95D-0349 [txt][pdf]Comments due by March 8,1999 The draft guidance Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product; Availability. Pages CBER9864, Docket No. 98D-0401 [txt][pdf] The draft guidance