Welcome to the Kids' Library!

Guidance for clinical investigators, sponsors, and IRBs adverse event reporting to IRBs : improving

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, [2009] 2009

Guidance for industry E2B(M), data elements for transmission of individual case study reports, quest

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, [2005] 2005

Guidance for industry E2BM data elements for transmission of individual case safety reports.

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, [2002] 2002

Guidance for industry granularity document : annex to 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, [2005] 2005

Guidance for industry M4, the CTD, efficacy questions and answers.

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, [2004] 2004

Guidance for industry M4, the CTD, general questions and answers.

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, [2004] 2004

Guidance for industry submitting marketing applications according to the ICH-CTD format, general con

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

Revision of the ICH guideline on clinical safety data management data elements for transmission of

[Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005] 2005