Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff certifications to accompany drug, biological product and device applications/submissions : compliance with Section 402(j) of the Public Health Service Act, added by Title VIII of the Food and Drug Administration Amendments Act of 2007.

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Bibliographic Details
Corporate Authors: United States. Food and Drug Administration. Office of Policy, United States. Food and Drug Administration. Office of the Commissioner
Format: Government Document Electronic eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Policy : Office of the Commissioner, [2009]
Physical Description:
1 online resource (10 pages)
Subjects:
Drugs -- Certification -- Government policy -- United States.
Biological products -- Certification -- Government policy -- United States.
Medical instruments and apparatus -- Certification -- Government policy -- United States.
Online Access:https://purl.fdlp.gov/GPO/LPS116943
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Holdings details from CMU Gov Pub Electronic C502
Copy 1 CMU Gov Pub Electronic HE 20.4702:C 33/2 Online

Internet

https://purl.fdlp.gov/GPO/LPS116943
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