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Approved PMA List Posted

09/26/2008

Federal Register Notice: FDA is publishing a list of approved PMAs whose safety and effectiveness summaries are available through ...

MedWatch Info Sent to OMB

09/24/2008

Federal Register Notice: FDA’s proposed collection of information, “MedWatch: Food and Drug Administration Medical Pro...

Panel to Discuss Genzyme BLA

09/24/2008

Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 10/21, from 8 a.m. to 5 p.m. ...

Finished Drug GMP Info Sent to OMB

09/24/2008

Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practice Regulations fo...

FDA Corrects Harmonization Notice

09/22/2008

Federal Register Notice: FDA is correcting a document number in a 7/11 Federal Register notice that announced the availability of ...

Info on Accredited Persons Inspections Sent to OMB

08/29/2008

Federal Register Notice: FDA’s proposed collection of information, “Requests for Inspection Under the Inspection by Ac...

Info on Fast Track Programs Sent to OMB

08/25/2008

Federal Register Notice: FDA’s proposed collection of information, Guidance for Industry: Fast Track Drug Development Progra...

FDA Proposes Info Collection on Drug Use in Pregnancy

08/25/2008

Federal Register Notice: FDA submits a proposed collection of information, “Mental Models Study of Communicating With Health...

Public Hearing on Pediatric OTC Cough/Cold Drugs

08/25/2008

Federal Register Notice: FDA will hold a public hearing 10/2 to obtain input on over-the-counter cough and cold drugs marketed for...

Info Sent to OMB on Certifications Accompanying Applications

08/25/2008

Federal Register Notice: FDA’s proposed collection of information, “Certification to Accompany Drug, Biological Produc...