Guideline for the format and content of the chemistry, manufacturing, and controls section of an application.

Description

Related Names

Center for Drugs and Biologics (U.S.)

Language(s)

English

Published

Rockville, Md. : Center for Drugs and Biologics, Food and Drug Administration, Dept. of Health and Human Services, 1987.

Subjects

Drug Approval > Drug Approval / United States.
Investigational New Drug Application > Investigational New Drug Application / methods > Investigational New Drug Application / methods / United States.
Drugs > Drugs / Law and legislation > Drugs / Law and legislation / United States.
Pharmaceutical chemistry > Pharmaceutical chemistry / United States.

Note

"February 1987."
Shipping list no.: 87-246-P.

Physical Description

11 p. ; 28 cm.

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