FDA"s regulation of the new drug Merital
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FDA"s regulation of the new drug Merital fifteenth report by United States. Congress. House. Committee on Government Operations.

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Published by U.S. G.P.O. in Washington .
Written in English

Subjects:

  • United States. -- Food and Drug Administration,
  • Antidepressants -- United States,
  • Anticonvulsants -- United States

Book details:

Edition Notes

Statementby the Committee on Government Operations
SeriesHouse report / 100th Congress, 1st session -- 100-206
The Physical Object
Paginationvi, 95 p. ;
Number of Pages95
ID Numbers
Open LibraryOL14283755M

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  Get this from a library! Oversight of the new drug review process and FDA's regulation of Merital: hearing before a subcommittee of the Committee on Government Operations, House of Representatives, Ninety-ninth Congress, second session, [United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources . The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions. Get this from a library! FDA's regulation of the new drug Versed: hearings before a subcommittee of the Committee on Government Operations, House of Representatives, One Hundredth Congress, second session, May 5 [United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee.]. Get this from a library! FDA's deficient regulation of the new drug Versed: seventy-first report. [United States. Congress. House. Committee on Government Operations.].

The pharmaceutical or drug quality-related regulations appear in several parts of Ti including sections in parts , , , , and Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation. Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases. U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD INFO-FDA () Contact FDA. The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.

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