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FDA Releases Modifications to Consensus Standards

03/18/2009

Federal Register Notice: FDA is publishing the modifications it is making to the list of standards the agency recognizes for use i...

Panel to Discuss Risk Communication Plan

03/05/2009

Federal Register Notice: FDA’s Risk Communication Advisory Committee will meet 4/30, from 8 a.m. to 5 p.m. and 5/1, from 8 a...

Comments Sought on Blood Cell Separator

03/02/2009

Federal Register Notice: FDA is seeking comments on the collection of information on Class 2 special controls for automated blood ...

FDA OKs IVX sANADA for Bovine Parasites

03/02/2009

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an IVX Animal Health supplemental ...

Device Recall Info Sent to OMB

02/26/2009

Federal Register Notice: FDA’s proposed collection of information, “Medical Device Recall Authority — 21 CFR Par...

Bill to Ban Generic ‘Payoffs’

02/06/2009

Sens. Herb Kohl (D-WI) and Chuck Grassley (R-IA) have introduced S. 369, the Preserve Access to Affordable Generics Act, to stop b...

Drop or Trim These FDA Programs: Miller

02/06/2009

Former FDAer (1979-93) Henry Miller, now a Hoover Institution fellow, says FDA would be a good place for the Obama administration ...

Guidance on Certifications Accompanying Applications

01/21/2009

Federal Register Notice: FDA is making available a guidance for industry entitled, Guidance for Sponsors, Industry, Researchers, I...

Guidance on Developing Products Under the Animal Rule

01/21/2009

Federal Register Notice: FDA is making available a draft guidance, Animal Models — Essential Elements to Address Efficacy Un...

Women’s Health Office to Hold Meeting

01/12/2009

Federal Register Notice: FDA’s Office of Women's Health will hold a meeting, “Women's Health Dialog” 2/9 for dir...