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Access to unapproved drugs : FDA policies on compassionate use and emergency use authorization

Thaul, Susan, author.
[Washington, D.C.] : Congressional Research Service, 2018- 2018

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 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