Guidance for industry efficacy studies to support marketing of fibrin sealant products manufactured for commercial use.
Saved in:
Other Authors: | Center for Biologics Evaluation and Research (U.S.) |
---|---|
Format: | Electronic |
Language: | English |
Published: |
Rockville, MD :
U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,
[1999]
|
Physical Description: |
i, 3 pages : digital, PDF file. |
Subjects: | |
Online Access: |
https://purl.fdlp.gov/GPO/LPS113530 |
In Prospector
Similar Items
-
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"
Published: (1999) -
Points to consider in the manufacture and testing of monoclonal antibody products for human use
Published: (1997) -
Guidance for industry year 2000 date change for computer systems and software applications used in the manufacture of blood products
Published: (1998) -
Career development programs guide
Published: (1987) -
The NIH Training Center
Published: (1987)