NEW PROTOCOL FOR REGISTRATION OF DRUGS, FOODS, COSMETICS, AND MEDICAL DEVICES
National Administrative Register [ BFAD BUREAU CIRCULAR NO. 4, S. 1999, February 03, 1999 ]
Effective February 4, 1999 the following changes in registration protocol will be implemented:
- Samples for physico-chemical analysis are not required. However, samples may be submitted for physical evaluation or specification verification;
- Complete documentation to support claims of safety, efficacy, identity, and quality must be submitted. Approval/disapproval will be based on completeness of submitted documents.
For your guidance.
Adopted: 3 Feb. 1999
(SGD.) WILLIAM D. TORRES
Director