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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...

Comments Sought on Feed Mill Licensing

08/25/2006

Federal Register Notice: FDA is seeking comments from medicated feed manufacturers on the medicated feed mill licensing system and...

FDA Looks to Univ. of Mississippi for Natural Products Research

08/25/2006

Federal Register Notice: FDA intends to receive and consider a single source competing continuation application for the award of a...

Immunohematology Workshop on Molecular Methods

08/21/2006

Federal Register Notice: FDA has scheduled a public workshop, "Molecular Methods in Immunohematology" 9/25-26 to gather and review...

Comments Sought on a Unique Device ID System

08/11/2006

Federal Register Notice: FDA is requesting comments to help the agency understand how the use of a unique device identification sy...

Nanotechnology Material Product Public Meeting

08/11/2006

Federal Register Notice: FDA will hold a public meeting 10/10, on FDA-regulated products containing nanotechnology materials. The ...

Detroit District and SoCRA to Hold Workshop

08/11/2006

Federal Register Notice: FDA’s Detroit District, in cooperation with the Society of Clinical Research Associates (SoCRA), will hol...