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Mercks Covid Drug has 52% Risk Reduction: FDA

[ Price : $8.95]

An FDA advisory committee briefing document says Mercks oral antiviral molnupiravir is associated with a relative risk reduction ...

Regulatory Review Period for Immunomedics Trodelvy

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Immunomedics breast cancer ...

MDR and QS Violations at Smiths Medical

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FDA warns Minneapolis-based Smiths Medical about Medical Device Reporting and Quality System violations in its work as a specifica...

De Novo Classification Rule Webinar

[ Price : $8.95]

FDA schedules a 12/14 Webinar on the medical device de novo classification process and its guidance document updates.

Feds Say Frenchman Made False Statements to FDA

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The Justice Department says a French national has been charged with making false statements to FDA to fraudulently obtain control ...

Pear Therapeutics Breakthrough for Alcohol-use App

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FDA grants Pear Therapeutics a breakthrough device designation for its reSET-A PDT (Prescription Digital Therapeutic) product cand...

Multiple Violations Found in Surgenex Inspection

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FDA warns Scottsdale, AZ-based Surgenex about CGMP and other violations in its production and distribution of cellular products fo...

FDA Reclassifying HIV Viral Load Tests

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Federal Register notice: FDA proposes to reclassify human immunodeficiency virus viral load monitoring tests from Class 3 to Class...

Info Collection Revision on INDs

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Federal Register notice: FDA seeks comments on an information collection revision entitled Investigational New Drug Applications ...

FDA Approves Takedas Livtencity

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FDA has approved Takedas Livtencity as the first approved treatment for adults and pediatric patients with post-transplant cytomeg...