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...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...10/01/2007
Federal Register Notice: FDA plans to take enforcement action against unapproved drug products containing hydrocodone bitartrate, ...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...09/27/2007
Federal Register Notice: FDA is making available a document entitled Guidance for Industry: Toxicity Grading Scale for Healthy Adu...09/27/2007
Federal Register Notice: FDA is requesting nominations for voting members to serve on the Veterinary Medicine Advisory Committee. ...09/26/2007
Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Pfizer supplemental NADA that ad...09/24/2007
As if to help clear the decks at CDER, whose drug-safety flounderings more than anything else provoked passage of the Democrat-dri...