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Guide on Notifying CDRH on Discontinued Products

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FDA updates a guidance entitled Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Se...

FDA Troubled by Chinese Firms Using Fictitious U.S. Agent

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FDA faces another Covid-19 debacle as it deals with over 1,300 Chinese firms providing medical protective equipment that registere...

FDA OKs Expansion of Obesity Study

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FDA approves the expansion of a USGI Medical pilot study of it obesity-treating endoscopic procedure known as POSE 2.0.

Mylan Urges Faster ANDA Approval for MS Generic

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Mylan says it is urging FDA to speed up its review of the companys ANDA for a generic copy of Biogens multiple sclerosis (MS) drug...

Guide on GMP Considerations Due to Infected Employee

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FDA posts a guidance entitled Good Manufacturing Practice Considerations for Responding to Covid-19 Infection in Employees in Drug...

Oncologic Panel to Review GSK Myeloma BLA

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Federal Register notice: FDA announces a 7/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review ...

Notice Corrected on ANDAs Withdrawn

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Federal Register notice: FDA corrects a 2/12/2019 notice that announced the withdrawal of approval of 12 ANDAs from multiple appli...

FDA OKs Dupixent Pre-filled Pen for At-Home Use

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FDA approves a 300 mg single-dose pre-filled pen for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab).

Evokes Gimoti Approved for Diabetic Gastroparesis

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FDA approves an Evoke Pharma NDA for Gimoti (metoclopramide) nasal spray, indicated for the relief of symptoms in adults with acut...

Rare Pediatric Disease Status for Gaboxadol

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FDA grants Ovid Therapeutics a rare pediatric disease designation to OV101 (gaboxadol) for treating Angelman syndrome.