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4. A Physician's Guide to Information Available from the FDA about New Drug Approvals.

Author

Hassall, Thomas H. and Fredd, Stephen B.

Subjects
PUBLIC records, GOVERNMENT information, GOVERNMENT paperwork, MEMORANDUMS, DRUG approval
Abstract

Provides information on documents that are created and maintained in the course of the U.S. Food and Drug Administration's regulatory process review. Review documents including medical, pharmacology and chemistry; Division Director's memorandum; Summary Basis of Approval; Advisory committee documents; Process of requesting copies of the documents.

Published
1989

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