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AAM Praises Controlled Correspondence Guidance

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The Association for Accessible Medicines praises the FDA revision of a draft guidance on generic drug controlled correspondence to...

FDA Publishes 3 X-Ray Guidances

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FDA publishes three guidances on aspects of x-ray system regulation.

FDA Accepts Elranatamab BLA for Priority Review

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FDA will give priority review with a decision expected this year on a Pfizer BLA for elranatamab to treat some multiple myelomas.

Artificial Tears Warning Expanded

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FDA expands its warning against using specific artificial tears products to now include Delsam Pharmas Artificial Eye Ointment due...

RapidAI RV/LV Analyzer for Pulmonary Embolism Cleared

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FDA clears a RapidAI 510(k) for Rapid RV/LV, a tool for physicians to quickly assess the ratio between the right ventricle and the...

High Court Refuses to Hear J&J Mesh Case

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The U.S. Supreme Court declines to hear a Johnson & Johnson case that sought the high courts review and reversal of a California C...

Public Meeting on Long Covid Drug Development

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Federal Register notice: FDA announces a 4/25 public meeting entitled Patient-Focused Drug Development for Long Covid.

FDA Priority Review for Regeneron Pozelimab

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FDA accepts for priority review a Regeneron BLA for pozelimab to treat CHAPLE disease in children and adults.

Akebia Vadadustat Dispute Resolution Delayed

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FDA says Office of New Drugs director Peter Stein will decide an Akebia Therapeutics formal dispute resolution request over the co...

FDA Extends Astellas Fezolinetant PDUFA Action Date

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FDA extends to 5/22 the PDUFA priority review action date for Astellas fezolinetant to treat some menopausal vasomotor symptoms.