This guidance applies to all sponsors who submit non-clinical study data from a Clinical Trial Application (CTA), CTA Amendment (CTA-A), Drug Identification Number (DIN) Application and applications to support a post-DIN change, New Drug Submission (NDS), Abbreviated New Drug Submission (ANDS) and submissions to support a post-Notice of Compliance (Post-NOC) change, that is, Supplement to an NDS (SNDS), Supplement to an ANDS (SANDS), and Notifiable Change (NC). Non-clinical studies include all in vitro and in vivo testing, not involving human subjects, performed to determine the safety of human drugs .

Questions and Answers to: Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice

Link to the website:

http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201004&RIN=0910-AG47

SPAQA Vorstand

Liebe Mitglieder und Nicht-Mitglieder, wir freuen uns ihnen mitteilen zu können, dass es seit dem 3. Mai 2011 einen neu zusammengesetzten Vorstand gibt.

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

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

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