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FDA Grants FzioMed Dispute Resolution Panel Review

[ Price : $8.95]

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...

FDA Clears Ethicon Hemostasis Device

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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

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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

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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

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

FDA Approves Cialis Label Addition

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FDA approves an Eli Lilly product label addition for Cialis (tadalafil) to include data from a 26-week study that showed Cialis 5 ...

CDER, Duke Plan Investigator Training

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Federal Register Notice: CDERs Office of Medical Policy and Duke University plan a training course for clinical investigators 11/1...

Animal Drug Regs Reflect July Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect July approval actions and also to reflect a sponsor...

Panel Backs Gileads Sofosbuvir for Hepatitis C

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An FDA advisory committee votes (15 to 0) to recommend approval of Gileads sofosbuvir to be used in combination with other agents ...