Search Results - [Dept. of Health and Human Services, Food and Drug Administration],
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Guidance for industry providing regulatory submissions in electronic format, drug establishment registration and drug listing
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2009“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”Description: 13 pages : digital, PDF file.
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2
The open public hearing FDA advisory committee meetings
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2004“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”Description: 1 online resource (7 pages)
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3
Guidance for institutional review boards (IRBs) frequently asked questions, IRB registration
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2009“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”Description: 1 online resource (7 pages)
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4
Guidance for clinical investigators, sponsors, and IRBs adverse event reporting to IRBs : improving human subject protection
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2009“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”Description: 1 online resource (6 pages)
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5
Guidance for industry providing regulatory submissions in electronic format, drug establishment registration and drug listing
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, 2008“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,…”Description: 11 pages : digital, PDF file.
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6
Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff certifications to accompany drug, biological product and device applications/sub...
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Policy : Office of the Commissioner, 2009“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Policy : Office of the Commissioner,…”Description: 1 online resource (10 pages)
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7
Guidance for industry Prescription Drug Marketing Act (PDMA) requirements, questions and answers
Published: 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“…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,…”Description: 1 online resource (4 pages)
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Guidance for industry collection of race and ethnicity data in clinical trials
Published: 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“…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,…”Description: 18 pages : digital, PDF file.
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Guidance for industry standards for securing the drug supply chain : standardized numerical identification for prescription drug packages
Published: 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“…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,…”Description: 1 electronic text : HTML file.
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