PDF-Guidance for Clinical Investigators Sponsors and Investigational New D

NOTE A stay is in effect for partsof subsection VID of this guidance dditional information about this staycan be found inthe Notice of Stay that published in the Federal Registerof October 30 201580. S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluatio n and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health Office of Good Clinical Practice May 2014 Contains S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologics Evalua tion and Research CBER Center for Food Safety and Applied Nutrition CFSAN September 2013 ClinicalMedical Comments and suggestions regarding this draft document should be subm itted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http 3 1 Research ethics committee approval3 2 Grounds for objection 4 3 Labelling of medical devices fdagovScienceResearchSpecialTopicsRunningClinicalTrialsGuidancesInformationSh eetsandNoticesdefaulthtm US Department of Health and Human Services Food and Drug Administration June 2010 Procedural brPage 2br Contains Nonbinding Recommendations Informa S Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER May 2010 Procedural brPage 2br Contains Nonbinding For questions regarding this document contact Sally Hojvat, Ph.D., at 240-276-0496 or by email at sally.hojvat@fda.hhs.gov.Office of Center for Biologic Evaluation and Research A Business Overview . Shannon . Staton. . PharmD. 2016. About. Contract research organizations (CROs) provide clinical trial and other research support services for:. Pharmaceutical . industry. Biotechnology industry. .. Jeffrey Moscow, M.D.. James A. Zwiebel, M.D.. Investigational Drug Branch. Cancer Therapy Evaluation Program, NCI. Patricia . LoRusso. , D.O.. Yale University. CTEP Young Investigator Meeting. Today’s Agenda. : . The Chemistry, Manufacturing and Controls (CMC) Review. Dorota Matecka, Ph.D. . Office of Pharmaceutical Quality (OPQ), CDER. Outline. Pharmaceutical Quality. CMC Requirements for INDs . CMC Safety Concerns. http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsan dNotices/default.htm U.S. Department of Health and Human Services Food and Drug Administration Offic Daniel R. LevinsonInspector General January 2009 OEI-05-07-00730 THE FOOD AND DRUG ADMINISTRATION’S OVERSIGHT OF CLINICAL INVESTIGATORS’ FINANCIAL INFORMATION Office of Inspector Gene Once you’ve logged into WebEx, please select one of the . following audio options:. Call Using Computer. I Will Call In (please enter the ID number provided by WebEx). DO NOT SELECT . the “Call Me” option..