Reviewer guidance : conducting a clinical safety review of a new product application and preparing a report on the review.

Format:

Book

Government document

Contributor:

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

Language:

English

Subjects (All):

Clinical trials--Reporting--Government policy--United States.

Clinical trials.

Drug approval--Government policy--United States.

Drug approval.

United States.

Physical Description:

1 online resource (79 pages)

Other Title:

Conducting a clinical safety review of a new product application and preparing a report on the review

Place of Publication:

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2005]

Notes:

"Good review practices."

"February 2005."

OCLC:

466807023