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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 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 FDA staff submission and resolution of formal disputes regarding the timel

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

Guidance for industry formal meetings between the FDA and sponsors or applicants.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2009] 2009

Guidance for industry M4, organization of the CTD.

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

Guidance for industry M4E, the CTD, efficacy.

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

Guidance for industry M4Q, the CTD, quality.

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

Guidance for industry M4S, the CTD, safety.

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

Guidance for industry M4S, the CTD, safety appendices.

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

Guidance for industry for the submission of chemistry, manufacturing and controls and establishment

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [1999] 1999

Information sheet guidance for institutional review boards and clinical investigators (continuing re

[Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, 1998?] 1998

Reviewer guidance conducting a clinical safety review of a new product application and preparing a r

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2005] 2005