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Public Meeting on Animal Drug User Fee Act

03/13/2007

Federal Register Notice: FDA will hold a public meeting 4/24 on the Animal Drug User Fee Act of 2003 to seek public comments on th...

FDA Seeks Pilot Participants to Submit CRFs

03/13/2007

Federal Register Notice: CDER and CBER are seeking sponsors interested in participating in a pilot project to test the submission ...

FDA Approves 2 Bayer NADAs for Dogs, Cats

03/09/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of two Bayer Healthcare NADAs that pr...

Guidance on Animal Drug User Fees

03/09/2007

Federal Register Notice: FDA is making available the Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waiver/Reduct...

FDA OKs 2 Intervet Food Safety Warnings

03/09/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of two Intervet, Inc. supplemental NA...

FDA OKs Fort Dodge OTC sNADA

03/09/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Fort Dodge Animal Health supplem...

FDA OKs Bayer Enrofloxacin Labeling Change

03/09/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Bayer HealthCare LLC supplementa...

FDA OKs Ivy Labs Heifer Feed

03/08/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Ivy Laboratories, Division of I...

Guidance on FDA’s Drug Safety Communications

03/07/2007

Federal Register Notice: FDA is making available a guidance entitled Drug Safety Information — FDA's Communication to the Pu...

Lamictal Not Withdrawn from Sale for S&E

03/05/2007

Federal Register Notice: FDA has determined that GlaxoSmithKline’s antiepileptic drug Lamictal (lamotrigine) tablets, 50 mg ...