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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 collection of race and ethnicity data in clinical trials.

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 : Center for Devices and Radiological Health : Office of the Commissioner, [2005] 2005

Guidance for industry computerized systems used in clinical investigations.

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

Guidance for industry Prescription Drug Marketing Act (PDMA) requirements, questions and answers.

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

Guidance for industry providing regulatory submissions in electronic format, drug establishment regi

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

Guidance for industry providing regulatory submissions in electronic format, drug establishment regi

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, [2008] 2008

Guidance for industry standards for securing the drug supply chain : standardized numerical indentif

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner : Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER) : Office of Regulatory Affairs, [2009] 2009

Guidance for institutional review boards (IRBs) frequently asked questions, IRB registration.

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

Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff

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