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Women’s Health Workshop Planned

08/15/2007

Federal Register Notice: FDA’s Office of Women's Health will hold a workshop to develop a women's health information sharing...

OMB OKs Info on Clinical Hold Responses

08/13/2007

Federal Register Notice: FDA’s collection of information entitled “Submitting and Reviewing Complete Responses to Clin...

ICH Prep Meeting Scheduled

08/13/2007

Federal Register Notice: FDA is sponsoring a public meeting entitled “Preparation for ICH meetings in Yokohama, Japan,&rdquo...

FDA OKs B.L. Mitchell ANADA for Finfish

08/13/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a B.L. Mitchell ANADA that provide...

FDA OKs G.C. Hanford ANADA for Horses

08/13/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a G.C. Hanford Manufacturing ANADA...

OMB OKs Info on Electronic Labeling Submissions

08/10/2007

Federal Register Notice: FDA’s collection of information, “Requirements for Submission of Labeling for Human Prescript...

OMB Approves Info on Environmental Impact

08/10/2007

Federal Register Notice: FDA’s collection of information entitled “Environmental Impact Considerations” has been...

Surgical Suture Classified into Class 2

08/03/2007

Federal Register Final rule: FDA is classifying the absorbable poly(hydroxybutyrate) surgical suture produced by recombinant deoxy...

Rates Listed for FY ’08 Animal Drug User Fees

08/02/2007

Federal Register Notice: FDA is announcing the rates and payment procedures for FY 2008 animal drug user fees: $172,500 for a new ...

FDA OKs Norbrook Labs ANADA

08/02/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Norbrook Laboratories ANADA that...