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Comments Sought on Patent Term Regulations

[ Price : $8.95]

Federal Register Notice: Federal Register Notice: FDA seeks comments on patent term restoration regulations on due diligence petit...

Comments Sought on Communications Studies of Biological Products

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Federal Register Notice: FDA seeks comments on communications studies about FDA-regulated biological products.

Hearing on Biologics Price Competition and Innovation Act

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Federal Register Notice: FDA will hold a public hearing 11/2-3 on implementing the Biologics Price Competition and Innovation Act ...

Watson Labs ANDA for Generic Azilect

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Watson Laboratories files an ANDA for rasagiline mesylate 0.5 and 1.0 mg tablets, a generic copy of Teva Neuroscience's Azilect ta...

Actelion Not Following PADE Reporting Requirements

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FDAs San Francisco District Office warns Actelion that it is violating regulations by not promptly reporting deaths in patients ta...

FDA Accepting Applications for Pan American Health Agreement

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Federal Register Notice: FDA plans to accept an application to award a cooperative agreement to the Pan American Health Organizati...

Azdone Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Azdone tablet, 5mg/500mg was not withdrawn for reasons of safety or effectiveness.

FDA to Accept Applications for World Animal Health Agreement

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Federal Register Notice: FDA intends to accept an application for a cooperative agreement to the World Organization for Animal Hea...

Panel to Discuss NSAID Complications

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee will meet 11/4 to discuss evaluation of gastrointestinal c...

FDA Amends Notice on Panel Meeting Discussing Melanoma Detector

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Federal Register Notice: FDA amends the notice of an 11/18 meeting of the General and Plastic Surgery Devices Panel to change the ...