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FDA Grants, Denies Teva ProAir Petition

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FDA says it would determine on a case-by-case basis whether an ANDA or 505(b)(2) application citing Tevas ProAir as the reference ...

Abrams Recalls Sterile Compounded Products

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Abrams Royal Pharmacy recalls all unexpired lots of its sterile compounded products due to a lack of sterility assurance.

FDA Clears Royal Phillips Breast Density App

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FDA clears a Royal Philips 510(k) for the Spectral Breast Density Measurement Application for its MicroDose SI full-field digital ...

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...

Morrison Promoted to ORA Operations Assistant Commissioner

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FDA Office of Commissioner crisis management director Ellen Morrison moves up to Office of Regulatory Affairs assistant commission...