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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 12:12:20
Managing Clinical Trials   by  on 2010-07-15 16:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 10:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 09:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 09:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 11:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 01:40:32
 Subject :US FDA new rule on reporting information regarding falsification of d.. 2010-02-25 20:47:33 
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Subject :US FDA new rule on reporting information regarding falsification of data

Dear Friends,

The Food and Drug Administration is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data involving studies including, but not limited to, clinical investigators, nonclinical laboratory studies, and clinical studies in animals.

The proposed rule is now available using the following web link: http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf.

Comments to this proposed rule are due by May 20, 2010.

Kind regards,
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