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PDUFA Fees for FY ’08 Published

10/12/2007

Federal Register Notice: FDA is announcing the rates for prescription drug user fees for FY 2008. The rates for application fees f...

Public Workshop on Cell/Scaffold Products

10/12/2007

Federal Register Notice: FDA, CBER, CDRH, and the National Institute of Standards and Technology are announcing a public workshop ...

Error Corrected in Electrocardiograph Electrodes Guidance

10/12/2007

Federal Register Notice: FDA is correcting a docket number in a notice that appeared in the 10/4 Federal Register on the availabil...

Latest FDA Warning Letters

10/11/2007

This week FDA posted its latest batch of Warning Letters. It can be downloaded in PDF format by clicking on the link following eac...

FDA’s Plate Full of PDUFA Initiatives

10/11/2007

Now that FDA has its new five-year Prescription Drug User Fee Act (PDUFA) agreement in place, the agency’s plate appears ful...

FDA Moves Against Unapproved Hydrocodone

10/01/2007

Federal Register Notice: FDA plans to take enforcement action against unapproved drug products containing hydrocodone bitartrate, ...

Procedure Change to Joint Advisory Meeting

10/01/2007

Federal Register Notice: FDA is announcing an amendment to 8/16 notice of a joint meeting of the Nonprescription Drugs Advisory Co...

Guidance on Vaccine Trial Toxicity Scale

09/27/2007

Federal Register Notice: FDA is making available a document entitled Guidance for Industry: Toxicity Grading Scale for Healthy Adu...

Nominations Sought for Veterinary Medicine Panel

09/27/2007

Federal Register Notice: FDA is requesting nominations for voting members to serve on the Veterinary Medicine Advisory Committee. ...

FDA OKs Pfizer sNADA for Bovine Respiratory Disease

09/26/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Pfizer supplemental NADA that ad...