Guidance for industry : comparability protocols, chemistry, manufacturing, and controls information.

Format:

Book

Government document

Contributor:

Center for Biologics Evaluation and Research (U.S.)

Center for Drug Evaluation and Research (U.S.)

Center for Veterinary Medicine (U.S.)

Language:

English

Subjects (All):

Medical protocols--United States.

Medical protocols.

Drug approval--United States.

Drug approval.

Veterinary drugs.

United States.

Physical Description:

1 online resource (16 pages)

Other Title:

Comparability protocols, chemistry, manufacturing, and controls information

Place of Publication:

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003]

Notes:

"Center for Biologics Evaluation and Research (CBER)."

"Center for Veterinary Medicine (CVM)."

"Draft guidance."

"CMC."

"February 2003."

OCLC:

560428006