CDRHNew
Date: August 28, 2013
The following new items were added to the CDRH web pages on August 27, 2013. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Guidance for IRBs, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IDE is Needed; Availability
- Guidance - IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
- The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff
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