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CBERs Marks Would Resign on Premature Vaccine Approval

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CBER director Peter Marks says he would resign if the Trump Administration interfered in an approval decision to speed up access t...

Regulatory Review Period for Oxervate

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dompe Farmaceuticis Oxervat...

Public Meeting on CDER Standard Core Sets

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Federal Register notice: FDA announces an 8/28 virtual public meeting entitled Public Meeting on CDER Standard Core Sets: Clinical...

Pelvital Flyte Urinary Incontinence Therapy Cleared

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FDA cleared a Pelvital 510(k) for Flyte, an intravaginal home-use device that is intended to strengthen the pelvic floor muscles t...

Alert on Passive Protective Barrier Enclosures

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FDA alerts health care providers that the use of passive protective barrier enclosures when treating Covid-19 patients may pose an...

FDA Warns CBD Web Site Over Covid-19 Claims

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FDA cites Living Senior, Las Vegas, NV, over its www.blueribbonhemp.com Web site that markets CBD products for treating Covid-19 p...

Device Panel to Review TransMedics Donor Heart Care System

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Federal Register notice: FDA announces a 10/7 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel,...

Bayshore Recalls 2 Lots of Metformin

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Bayshore Pharmaceuticals recall two lots of metformin hydrochloride extended-release tablets due to the detection of N-nitrosodime...

Info Collection Extension on Focus Groups

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Federal Register notice: FDA sends to OMB an information collection extension on Focus Groups as Used by the Food and Drug Adminis...

Outsourcing Facility Registration Information Collection

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Federal Register notice: FDA seeks comments on a revised information collection on Registration of Human Drug Compounding Outsourc...