Guidance for industry for the submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use."

Format:

Book

Government document

Contributor:

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

Language:

English

Subjects (All):

Blood products--Evaluation--Government policy--United States.

Blood products.

Drug approval--Government policy--United States.

Drug approval.

Biologicals--Evaluation--Government policy--United States.

Biologicals.

Antibiotics--Evaluation--Government policy--United States.

Antibiotics.

United States.

Physical Description:

1 online resource (i, 27 pages)

Other Title:

Submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use"

Application to market a new drug, biologic or an antibiotic drug for human use

Place of Publication:

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [1999]

Notes:

Title from PDF title page (viewed on June 5, 2009).

"May 1999."

Includes bibliographical references (page 26).

OCLC:

371102581