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List of Approved PMAs is Updated

05/07/2004

Federal Register Notice: FDA is publishing a list of approved premarket approval applications that have PMA safety and effectivene...

Public Workshop Scheduled to Target Anthrax

05/07/2004

Federal Register Notice: FDA will hold a public workshop entitled “Strategies for Developing Therapeutics That Directly Targ...

Errors Corrected in Device Reporting Rule

05/07/2004

Federal Register Final rule: FDA is correcting inadvertent errors in a 4/8 Federal Register final rule that corrected a 3/10 FR fi...

Guidance on Combination Products and Dispute Resolution

05/04/2004

Federal Register Notice: FDA is making available a draft guidance for industry entitled Combination Products, Timeliness of Premar...

Animal Drug User Fee Rates Established

04/27/2004

Federal Register Notice: FDA is announcing the fee rates and payment procedures for product, establishment, and sponsor fees for f...

Authority Delegated for Clinical Laboratory Provisions

04/27/2004

Federal Register Delegation of Authority: HHS secretary Tommy Thompson, Secretary delegates to the FDA commissioner the authority ...

Errors Corrected in Guidance Notice

04/26/2004

Federal Register Notice: FDA is correcting inadvertent errors in a 4/8 Federal Register notice announcing the availability of a re...

Public Meeting to Prep for ICH Steering Committee

04/26/2004

Federal Register Notice: FDA will sponsor a public meeting entitled “Preparation for ICH Meetings in Washington, DC” t...

FDA Approves Fort Dodge Equine sNADA

04/23/2004

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug app...

FDA Proposes Toll-Free Number to Report Drug Side Effects

04/22/2004

Federal Register Proposed rule: FDA is proposing to require a statement on the labeling of approved human drug products that inclu...