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Antibiotics FDA needs to do more to ensure that drug labels contain up-to-date information : report

United States. Government Accountability Office.
[Washington, D.C.] : U.S. Govt. Accountability Office, [2012] 2012

Electronic drug labeling no consensus on the advantages and disadvantages of its exclusive use : rep

United States. Government Accountability Office, issuing body.
[Washington, D.C.] : United States Government Accountability Office, 2013. 2013

Guidance for industry adverse reactions section of labeling for human prescription drug and biologic

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, [2006] 2006

Guidance for industry bar code label requirements, 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, [2006] 2006

Guidance for industry clinical lactation studies; study design, data analysis, and recommendations f

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 clinical studies section of labeling for human prescription drug and biologica

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation, [2006] 2006

Guidance for industry patient-reported outcome measures, use in medical product development to suppo

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, [2006] 2006

Guidance for industry providing regulatory submissions in electronic format, content of labeling.

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 providing regulatory submissions in electronic format, prescription drug adver

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

Guidance for industry revising and ANDA labeling following revision of the RLD labeling.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2000] 2000

Guidance for industry SPL standard for content of labeling technical Qs & As.

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