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Corrections to ICH Prep Meeting Notice

10/01/2008

Federal Register Notice: FDA is correcting the 9/16 notice of a public meeting entitled “Preparation for International Confe...

Comments on Labeling Requirements Sought

09/29/2008

Federal Register Notice: FDA is seeking public comment on the information collection provisions of the agency’s requirements...

Authorized Generic Drug Info Required

09/29/2008

Federal Register Direct final rule/proposed rule: FDA is amending its regulations to require that the holder of an NDA submit cert...

Guidance on End-of-Phase 2A Meetings

09/26/2008

Federal Register Notice: FDA is making available a draft guidance for industry, End-of-Phase 2A Meetings. It provides information ...

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...