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Info Collection on Drug Compounding

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Federal Register notice: FDA seeks comments on an information collection revision entitled Human Drug Compounding, Repackaging, an...

FDA Unable to Approve Tysabri sBLA

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FDA sends Biogen a complete response letter on its sBLA for a new Tysabri route of administration.

AdvaMedDx Comments on FDA Viral Mutation Impact Guidance

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AdvaMedDx sends FDA recommendations for changes to an agency guidance on evaluating the impact of viral mutations on Covid-19 test...

Data Monitoring Committee Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Establishment and Operation of Clinica...

Medical Device Reporting Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Reporting 21 CFR Part ...

FDA De Novo for Dry Eye Device

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FDA grants Lumenis a de novo authorization for its newest intense pulsed light device for improving signs of dry eye disease.

Drugs Prices Higher in U.S. than 3 Other Countries: GAO

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A Government Accountability Office analysis says prices for 20 major prescription drugs were higher in the U.S. than in three othe...

Soliton 510(k) Cleared for Tattoo/Cellulite Device

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FDA clears a Soliton special 510(k) for modifications to its Resonic device and its use for tattoo removal and cellulite treatment...

FDA Should Require Better Cancer Drug Trial Representation: Study

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Academic medical center researchers document gaps in demographic representation for older adults and black patients in cancer ther...

Info Collection on User Fee Refund

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Federal Register notice: FDA seeks comments on an information collection extension entitled Electronic User Fee Payment Request Fo...