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FDA Clears Ethicon Hemostasis Device

[ Price : $8.95]

FDA clears an Ethicon Endo-Surgery 510(k) for the Harmonic Ace+ 7 Shears with Advanced Hemostasis, intended for use is sealing ves...

FDA Wins Against Cumberland Suit Over Generic Acetadote

[ Price : $8.95]

FDA wins a summary judgment in a case brought by Cumberland Pharmaceuticals that challenged the agencys decision to deny a citizen...

FDA Denies Petition Seeking Only Abuse-deterrent Opioids

[ Price : $8.95]

FDA denies a citizen petition request that the agency reject applications for new opioid medications without added safety features...

Actavis ANDA Filed for Generic Acanya

[ Price : $8.95]

Actavis files an ANDA to market a generic copy Dow Pharmaceutical Sciences and Valeant Pharmaceuticals Acanya Gel (clindamycin pho...

FDA Clears EndoChoice Fuse Gastroscope

[ Price : $8.95]

FDA clears an EndoChoice 510(k) for its new Fuse Gastroscope that has a field of view of 245 degrees.

Expanded Indication Approved for Lundbecks Sabril

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FDA approves Lundbecks Sabril (vigabatrin) as add-on therapy for treating refractory complex partial seizures in children aged 10 ...

FDA Denies it Promised Not to OK Abusable Opioids

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FDA contradicts a claim by a congressman that assured him it would not approve new opioids unless they had abuse-deterrent formula...

Info on Premarket Notification Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on premarket notification to the Office of Management a...

FDA Grants FzioMed Dispute Resolution Panel Review

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FDA agrees to reconsider its 10/2012 denial of a FzioMed PMA for Oxiplex/SP Gel that sought an indication for use as a surgical ad...

CDER Adds Professional Affairs, Stakeholder Director

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CDER hires former Discovery Channel chief medical expert John Whyte to serve as the Centers newly created professional affairs and...