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CDER Already Surpasses NME Approval Totals for Last Year

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CDER eclipses last years 27 new molecular entity (NME) drug product approvals by approving 34 applications through 10/15.

FDA Panel Backs Novartis Drug for Plaque Psoriasis

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FDAs Dermatologic and Ophthalmic Drugs Advisory Committee votes 7 to 0 to support the approval of Novartis AIN457 (secukinumab) fo...

FDA Accepts Merck, Sanofi Pediatric Vaccine BLA

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FDA accepts for review a Merck and Sanofi Pasteur BLA for their investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1.

FDA Posts GSK Letters to MDs on Vaccine Label Fading

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FDA posts a Dear Healthcare Provider letter from GlaxoSmithKline informing physicians about the potential for fading over time on ...

FDA Clears AnthroTronix DANA App for Psych Testing

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FDA clears an AnthroTronix 510(k) for its computerized cognitive test battery DANA, which is intended to provide clinicians with a...

FDA OKs Clinical Trial in Ebola Patients

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FDA approves a Phase 2 clinical trial protocol from Chimerix to begin clinical trials of brincidofovir in Ebola patients.

FDA Approves Abuse-deterrent Claim on Pfizers Enbeda

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FDA approves new abuse deterrent labeling for Pfizers painkiller Embeda (morphine sulfate and naltrexone hydrochloride) extended-r...

Will FDA Raise Cybersecurity Goals in Device Submissions?

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A client alert from law firm Sheppard, Mullin, Richter & Hampton hints at increased FDA scrutiny for medical devices that lend the...

FDA Publishes List of Device Standards

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Federal Register Notice: FDA publishes a modified list of recognized standards that it recognizes for use in premarket reviews.

CDER Revamp Includes Office of Pharmaceutical Quality

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CDER director Janet Woodcock announces a 1/5/15 Center reorganization that includes creation of a super-office Office of Pharmaceu...

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CDER Already Surpasses NME Approval Totals for Last Year

FDA Panel Backs Novartis Drug for Plaque Psoriasis

FDA Accepts Merck, Sanofi Pediatric Vaccine BLA

FDA Posts GSK Letters to MDs on Vaccine Label Fading

FDA Clears AnthroTronix DANA App for Psych Testing

FDA OKs Clinical Trial in Ebola Patients

FDA Approves Abuse-deterrent Claim on Pfizers Enbeda

Will FDA Raise Cybersecurity Goals in Device Submissions?

FDA Publishes List of Device Standards

CDER Revamp Includes Office of Pharmaceutical Quality

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Pay Per View

Home / Pay Per View

CDER Already Surpasses NME Approval Totals for Last Year

FDA Panel Backs Novartis Drug for Plaque Psoriasis

FDA Accepts Merck, Sanofi Pediatric Vaccine BLA

FDA Posts GSK Letters to MDs on Vaccine Label Fading

FDA Clears AnthroTronix DANA App for Psych Testing

FDA OKs Clinical Trial in Ebola Patients

FDA Approves Abuse-deterrent Claim on Pfizers Enbeda

Will FDA Raise Cybersecurity Goals in Device Submissions?

FDA Publishes List of Device Standards

CDER Revamp Includes Office of Pharmaceutical Quality

Categories

Top News

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