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FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and g

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008] 2008

Guidance for FDA reviewers premarket notification submissions for transfer sets (excluding sterile c

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2001] 2001

Innovation in America opportunities and obstacles : hearing before the Subcommittee on Competitivene

United States. Congress. Senate. Committee on Commerce, Science, and Transportation. Subcommittee on Competitiveness, Innovation, and Export Promotion.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2011. 2011

Premarket approval application filing review

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2003] 2003

Premarket approval application modular review

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2003] 2003

Real-time premarket approval application (PMA) supplements

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2006] 2006