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02. März 2010	Fragen & Antworten Behördendiskussionsrunde 2009
	Die Fragen & Antworten der Behördendiskussionsrunde 2009 sind unter Downloads/Behörden Diskussionsrunde 2009 verfügbar.

02. März 2010	FDA Warning Letter wegen Verstösse gegen GLP
	FDA's Center for Biologics Evaluation and Research versendete am 17. August 2009 einen Warning Letter wegen zahlreicher Verstösse gegen die GLP-Vorschriften im Code of Federal Regulations. FDA Warning Letter (GLP) 17-Aug-2009

05. März 2010	FDA Issues Proposed Rulemaking Impacting Sponsors
	The proposed rule would require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. http://edocket.access.gpo.gov/2010/2010-3123.htm

05. März 2010

FDA Issues Proposed Rulemaking Impacting Sponsors

The proposed rule would require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor.

http://edocket.access.gpo.gov/2010/2010-3123.htm

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