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ICH Meeting on Continuous Manufacturing, Other Topics

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FDA and Health Canada announce a 10/8 regional public consultation on recent International Council for Harmonization activities an...

Panexcell, Synchron Studies Are Unacceptable: FDA

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FDA says NDA and ANDA sponsors who submitted study data developed by Indias Panexcell Clinical Lab or Synchron Research Services m...

J&J Touts Vaccine Booster Data

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Johnson & Johnson reports new data showing increased protection against Covid-19 when a booster shot of its vaccine is administere...

Fibromyalgia Treatment Group Selling Unapproved New Drugs: FDA

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FDA warns the Fibromyalgia Treatment Group it is selling unapproved new drugs.

Guide on Controlled Correspondence Related to Quality

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FDA posts a draft guidance entitled Questions and Answers on Quality-Related Controlled Correspondence for generic drug developers...

First Lucentis Biosimilar Approved by FDA

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FDA approves a Samsung Bioepis and Biogen BLA for Byooviz (ranibizumab-nuna), the first biosimilar version of Genentechs age-relat...

OTC Monograph FDA Portal

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Federal Register notice: FDA makes available on its Web site certain final administrative orders, including for over-the-counter (...

False Positives With Abbott Covid Test: FDA

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FDA issues an alert about the potential for false positive results with Abbott Moleculars Alinity m SARS-CoV-2 AMP Kit and Alinity...

AbbVie sBLA for Skyrizi in Crohns Disease

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AbbVie files a BLA supplement for Skyrizi (risankizumab-rzaa) for treating patients 16 years and older with moderate to severe Cro...

Medtronic Unit Recalls Brain Aneurysm Stents

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Medtronics Micro Therapeutics unit recalls its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield...