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FDA, Duke Sign MOU on Cardiovascular Safety

10/16/2006

Federal Register Notice: FDA is providing notice of a memorandum of understanding between FDA and Duke University, on behalf of i...

Guidance on Investigating OOS Results

10/12/2006

Federal Register Notice: FDA is making available a guidance for industry entitled Investigating Out-of-Specification (OOS) Test R...

Review Period Corrected for Boniva

10/11/2006

Federal Register Notice; correction: A request for revision of the regulatory review period for Boniva was filed for the product o...

Nominations Sought for Device Panels

10/11/2006

Federal Register Notice: FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advis...