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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

Information sheet : guidance for institutional review boards and clinical investigators (acceptance

[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

Structure and content of clinical study reports

[Rockville, Md : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1996] 1996