News

 

Brenda Seidman is invited speaker on FDA GLPs and their significance to Chinese CRO development.

Date: June 12, 2008.

 

Brenda Seidman speaks in Taizhou, Jiangsu Province, P.R. China on “Good Laboratory Practice (GLP) in the U.S. and the Impact on China’s CROs” [New Drug Development and CRO Summit Forum International Conference]

 

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CDER

• Guidance for Industry and Review Staff. Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternative Route. March 2008. (Adobe pdf)
• Guidance for Industry. Safety Testing of Metabolites. February 2008. (Adobe pdf)

 

CDRH

• Guidance for Industry and FDA Staff. Expedited Review of Premarket Submissions for Devices. February 29, 2008 Guidance for Industry and FDA Staff. Recognition and Use of Consensus Standards. September 17, 2007. (Adobe pdf)

 

CDRH & CBER

• Guidance for Industry and FDA Staff. Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements. February 28, 2008. (Adobe pdf)

 

CDER, CDRH, & CBER

• Guidance for Industry. Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. February 2008. (Adobe pdf)
• Guidance for Industry. Pharmacogenomic Data Submissions – Companion Guidance. Draft Guidance. August 2007. (Adobe pdf)