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Animal Drug Sponsor Changed to Cross Vetpharm

07/22/2009

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for three NADAs and one ab...

FDA Withdraws 2 NADAs, 1 ANADA

07/22/2009

Federal Register Notice and Final rule: FDA is withdrawing approval of two NADAs (Wellmark International’s Zodiac Fleatrol F...

OMB OKs Info on Clinical Trial Data Monitoring

07/22/2009

Federal Register Notice: FDA’s collection of information, “Guidance for Clinical Trial Sponsors: Establishment and Ope...

OMB OKs Info on Notice of Participation

07/22/2009

Federal Register Notice: FDA’s collection of information entitled “Notice of Participation” has been approved by...

OMB OKs Info on Export Certificates

07/22/2009

Federal Register Notice: FDA’s collection of information, “Export of Food and Drug Administration Regulated Products: ...

Prescription Drug Marketing Act Info Sent to OMB

07/22/2009

Federal Register Notice: FDA’s proposed collection of information, “Prescription Drug Marketing Act of 1987; 21 CFR Pa...

Comments Sought On DTC Ad Study

06/22/2009

Federal Register Notice: FDA is seeking public comment on a proposed collection of information by the agency: “Experimental ...

Bioequivalence Recommendations Available

06/08/2009

Federal Register Notice: FDA is making available final product-specific bioequivalence (BE) recommendations. The recommendations p...

Guidance on Adding Toll-Free Number to Med Guides

06/08/2009

Federal Register Notice: FDA is making available a guidance for industry, Medication Guides —Adding a Toll-Free Number for R...

Draft BE Recommendations Available

06/08/2009

Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommend...