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Annual report

United States. Food and Drug Administration. Office of Combination Products.
Rockville, Md. : Food and Drug Administration, Dept. of Health and Human Services, [2003] 2003

FY ... performance report to the Congress for the Office of Combination Products as amended in the M

United States. Food and Drug Administration. Office of Combination Products.
Rockville, Md. : Food and Drug Administration, Dept. of Health and Human Services, [2004] 2004

Guidance for industry and FDA current good manufacturing practice for combination products.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2004] 2004

Guidance for industry and FDA staff application user fees for combination products.

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2005] 2005

Guidance for industry and FDA staff devices used to process human cells, tissues, and cellular and t

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2007] 2007

Guidance for industry and FDA staff early development considerations for innovative combination prod

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2006] 2006

Guidance for industry and FDA staff how to write a request for designation (RFD).

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, [2005] 2005

Guidance for industry and staff minimal manipulation of structural tissue jurisdictional update.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products : Center for Biologics Evaluation and Research, [2006] 2006

Guidance for industry new contrast imaging indication considerations for devices and approved drug a

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in Office of Commissioner : Center for Devices and Radiological Health (CDRH) : Center for Drug Evaluation and Research (CDER), [2008] 2008

Performance report to Congress for the Office of Combination Products as required by the Medical Dev

United States. Food and Drug Administration. Office of Combination Products.
Rockville, Md. : U.S. Food and Drug Administration, U.S. Dept. of Health and Human Services, [2004] 2005

Guidance for industry : postmarketing adverse event reporting for medical products and dietary suppl

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Counterterrorism and Emerging Threats : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition, [2008] 2008