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FDA OKs Schering NADA for Bovine Respiratory Disease

04/18/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Schering-Plough Animal Health Co...

Info on Drug Applications Sent to OMB

04/18/2008

Federal Register Notice: FDA’s proposed collection of information, “Application for Food and Drug Administration Appro...

Guidance on CMC Info for Human Gene Therapy INDs

04/10/2008

Federal Register Notice: FDA is making available a document, Guidance for FDA Reviewers and Sponsors: Content and Review of Chemis...

Info on Customer/Partner Surveys Sent to OMB

04/10/2008

Federal Register Notice: FDA’s proposed collection of information, “Customer/Partner Service Surveys” has been s...

FDA OKs Intervet NADA for Heifer Feed

04/10/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a new animal drug application (NAD...

Guidance for Human Somatic Cell Therapy INDs

04/10/2008

Federal Register Notice: FDA is making available a document, Guidance for FDA Reviewers and Sponsors: Content and Review of Chemis...

Info on Small Business Certification Sent to OMB

04/10/2008

Federal Register Notice: FDA’s proposed collection of information, “Medical Device User Fee Amendments of 2007; Foreig...

Corrections/Removals Report Info Sent to OMB

04/10/2008

Federal Register Notice: FDA’s proposed collection of information, “Reports of Corrections and Removals — 21 CFR...

Woodcock Took Job to Lead New Drug Safety Challenges

04/08/2008

Who would volunteer for one of the government’s toughest jobs just when Congress had given it a 157-page new law to implemen...

7 NADAs Withdrawn

04/04/2008

Federal Register Final rule: FDA is amending the animal drug regulations by removing those portions that reflect approval of seven...