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FDA OKs Merial NADA for Bovine Parasites

11/28/2011

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an original NADA filed by Merial L...

Taxotere Not Withdrawn for S&E

11/28/2011

Federal Register Notice: FDA has determined that Taxotere (docetaxel) injection, 40 mg/mL was not withdrawn from sale for reasons...

Guidance on IVDs to Detect Human Papillomaviruses

11/28/2011

Federal Register Notice: FDA is making available a guidance, Establishing the Performance Characteristics of In Vitro Diagnostic D...

Info on Condom Labeling Sent to OMB

11/18/2011

Federal Register Notice: FDA’s proposed collection of information, “Class 2 Special Controls Guidance Document: Labeli...

OMB OKs Info on Dietary Ingredient Premarket Notification

11/18/2011

Federal Register Notice: FDA’s collection of information entitled, “Premarket Notification for a New Dietary Ingredien...

Guidance on Medication Guides and REMS

11/18/2011

Federal Register Notice: FDA is making available a guidance, Medication Guides — Distribution Requirements and Inclusion in ...

Comments Sought on Device Recall Authority

11/16/2011

Federal Register Notice: FDA is seeking public comment on the information collection requirements for medical device recall author...

FDA Permanently Debars Reuben

11/16/2011

Federal Register Notice. FDA is issuing an order under the FDCA permanently debarring Scott S. Reuben, MD from providing services ...

Travatan Not Withdrawn for S&E

11/16/2011

Federal Register Notice: FDA has determined that Travatan (travoprost ophthalmic solution), 0.004%, was not withdrawn from sale fo...

Info on Extra-label Drug Use Sent to OMB

11/16/2011

Federal Register Notice: FDA’s proposed collection, “Extra-label Drug Use in Animals — 21 CFR 530” has bee...