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Lawmakers Ask HHS for Insight into Rising Generic Drug Prices

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Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) write HHS secretary Sylvia Burwell asking her to address significant...

How to Avoid a Hold on Device eCopy Submissions

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CDRH posts a resources listing for medical device makers submitting an electronic copy of their submissions.

Hospira Recalls 1 Lidocaine Lot

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Hospira recalls one lot of 1% lidocaine HCl for injection due to a confirmed customer report about particulate in a single unit.

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.

Spectrum Pharma Petitions FDA to Block Fusilev Generics

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Spectrum Pharmaceuticals petitions FDA asking that it not approve any ANDAs that seek to carve-out Fusilevs orphan drug exclusivit...

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.

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 ...