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Title Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff [electronic resource] : 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.

Imprint

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Policy : Office of the Commissioner, [2009]

Connect to
Connect to http://purl.access.gpo.gov/GPO/LPS116943

Copies

Location	Call No.	OPAC Message	Status
Axe Federal Documents Online	HE 20.4702:C 33/2	---	Available

Description	1 online resource (10 p.)
Note	"January 2009."
Subject	Drugs -- Certification -- Government policy -- United States.
	Biological products -- Certification -- Government policy -- United States.
	Medical instruments and apparatus -- Certification -- Government policy -- United States.
Added Author	United States. Food and Drug Administration. Office of Policy.
	United States. Food and Drug Administration. Office of the Commissioner.
Added Title	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
Gpo Item No.	0475 (online)
Sudoc No.	HE 20.4702:C 33/2