Research Catalog

Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances

Title
  1. Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances / Center for Drugs and Biologics, Food and Drug Administration, Department of Health and Human Services.
Published by
  1. Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1987.

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Details

Additional authors
  1. Center for Drugs and Biologics (U.S.)
Subject
  1. Drugs > United States
  2. Legislation, Drug
  3. Pharmaceutical Preparations > Manufacture
  4. Technology, Pharmaceutical > legislation & jurisprudence
  5. Investigational New Drug Application
  6. New drug applications
  7. Good manufacturing practices
Owning institution
  1. Columbia University Libraries
Note
  1. Shipping list no.: 87-246-P.
  2. "February 1987."