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UDI Expert Crowley Retires to Join Industry

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CDRH patient safety senior advisor Jay Crowley retires from FDA to join regulatory consulting firm USDM Life Sciences as vice pres...

Baxters New Hemophelia Bleeding Therapy Approved

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FDA approves Baxters Feiba indicated for preventing or reducing the frequency of bleeding episodes in patients with hemophilia A o...

Amgen Cholesterol Treatment Meets Phase 3 Study Endpoint

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Amgen reports that its Phase 3 DESCARTES study of evolocumab in patients with high cholesterol met its primary endpoint of percent...

FDA OKs AXIOS Stent for Pancreas Pseudocysts

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FDA approves an Xlumena de novo petition for the AXIOS Stent and Delivery System for treating pseudocysts that form in the pancrea...

Attorneys Advise Firms to Find Ways to Argue Preemption

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Attorneys writing the Drug and Device Law blog urge drug and medical device companies to argue federal preemption of off-label saf...

Sandoz Opens Follow-on Humira Phase 3 Trial

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Sandoz initiates a Phase 3 study of its biosimilar version of AbbVies Humira.

Info on Device Communications Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on testing commun...

Workshop on Endpoints on Intraocular Lenses

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Federal Register Notice: FDA plans a public workshop 3/28/14: FDA/American Academy of Ophthalmology (AAO) Workshop on Developing N...

FDA Modernizes Citizen Petition Regs to Include E-Submissions

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Federal Register Final rule: FDA modernizes its administrative regulations on submitting citizen petitions to explicitly provide f...

Health Firms Must Work Closely with FDA: Wharton Profs

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Wharton School of Business professors say that recent regulatory action against the personal genetic tests marketed by 23andMe spe...