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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...

FDA Shakeup: Galson Leaves, Woodcock Back to CDER

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...

FDA Corrects Error in Blood Products Rule

09/24/2007

Federal Register Proposed rule and direct final rule: FDA is correcting a typographical error in the codified section of a propose...

OMB OKs Info on Pharma Development Study

09/21/2007

Federal Register Notice: FDA’s collection of information, “Pharmaceutical Development Study” has been approved b...

Comments Sought on Radioactive Drugs Regs

09/21/2007

Public Meeting on IT Resources in Reviewing NDAs

09/21/2007

Federal Register Notice: FDA solicits comments on the information collection contained in regulations governing the use of radioac...

Trial Lawyers Win ‘Anti-preemption’ Language in FDA Bill

09/21/2007

Democrats buoyed by support from trial lawyers were successful in inserting anti-preemption language in the compromise FDA Amendme...

FDA Seeks to Boost Consumer Ad Comprehension

09/21/2007

Although the pharmaceutical industry routinely employs some of the most creative and sophisticated talent available in the field o...