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FDA posts a draft guidance entitled Questions and Answers on Quality-Related Controlled Correspondence for generic drug developers...

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...

Pfizer Touts Favorable Covid Jab Data in Children

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Pfizer and BioNTech announce results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody re...

FDA Complete Response on Verrica NDA

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FDA sends Verrica Pharmaceuticals a complete response letter on its NDA for VP-102 for treating the skin disease molluscum contagi...

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 (...