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Comments Sought on Feedback for Fast Track Products

11/20/2003

Federal Register Notice: FDA is seeking public comment on the information collection contained in the guidance for industry on Con...

Public Information Regs Corrected

11/20/2003

Federal Register Final rule: FDA is correcting the public information regulations to correct an error that was incorporated in the...

FDA OKs Cross Vetpharm ANADA

11/19/2003

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

FDA Seeks Info on Observance of Triptan Contraindication

11/17/2003

Federal Register Notice: FDA is seeking public comment on the proposed collection of information on FDA's burden estimates to dist...

Compliance Guide To Prevent BSE

11/10/2003

Federal Register Notice: FDA is making available a compliance program guidance manual entitled “Bovine Spongiform Encepholop...

Delcobese Not Withdrawn for S&E

11/10/2003

Federal Register Notice: FDA has determined that Delcobese (amphetamine adipate, amphetamine sulfate, dextroamphetamine adipate, d...

Wydase Not Withdrawn for S&E

11/06/2003

Federal Register Notice: FDA is announcing its determination that hyaluronidase for injection (Wydase) was not withdrawn from sale...

OMB OKs Info on Risk Management

11/06/2003

Federal Register Notice: FDA’s collection of information entitled “Impact of Risk Management Programs on the Practice ...

Accredited Device Manufacturers Posted

11/06/2003

Federal Register Notice: FDA is making available a list of persons who are accredited under certain circumstances to inspect eligi...

Approved PMAs Posted

11/06/2003

Federal Register Notice: FDA is publishing a list of premarket approval applications that have been approved to inform the public ...