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Info on Orphan Drug Form Sent to OMB

04/30/2008

Federal Register Notice: FDA’s proposed collection of information, “Orphan Drugs; Common European Medicines Agency/Foo...

Public Workshop on Artificial Pancreas

04/30/2008

Federal Register Notice: FDA, in collaboration with NIH and the Juvenile Diabetes Research Foundation is holding a public workshop...

Dietary Supplement Claim Info Sent to OMB

04/25/2008

Federal Register Notice: FDA’s proposed collection of information, “Draft Guidance for Industry: Substantiation for Di...

FDA Strengthens BSE Safeguards

04/25/2008

Federal Register Final rule: FDA is amending its regulations to prohibit the use of certain cattle origin materials in the food or...

Postmarketing Study Status Report Out

04/24/2008

Federal Register Notice: FDA is reporting, as required by FDAMA, on the status of postmarketing study commitments made by applican...

Public Workshop on Coronary Drug-Eluting Stent Guidance

04/24/2008

Federal Register Notice: FDA and AdvaMed are co-sponsoring a public workshop entitled “Coronary Drug-Eluting Stent (DES) Gui...

Device Panel Meeting Postponed

04/24/2008

Federal Register Notice: FDA is postponing the meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advis...

Meeting on Animal Feed Hazards

04/21/2008

Federal Register Notice: FDA will hold a public meeting 5/14, “Meeting to Present Changes to the Animal Feed Safety System (...

Public Meeting on Pet Food Standards

04/21/2008

Federal Register Notice: FDA is holding a public meeting 5/13 to obtain input from stakeholder groups, including, but not limited ...

Guidance on Certifications Accompanying Applications

04/18/2008

Federal Register Notice: FDA is making available a draft guidance for industry, Guidance for Sponsors, Industry, Researchers, Inve...