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FDA Orders Duodenoscope Postmarket Surveillance Studies

[ Price : $8.95]

FDA orders the three makers of duodenoscopes to conduct postmarket surveillance studies to better understand how the devices are r...

Merck Gains Accelerated Approval for Keytruda in Lung Cancer

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FDA grants Merck accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lun...

510(k) Blues: Morcellator Activist Calls for Shurens Resignation

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Philadelphia cardiothoracic surgeon Hooman Norchashm meets with CDRH director Jeffrey Shuren and calls for his resignation over hi...

Comments Sought on PDUFA Workload Adjuster

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Federal Register Notice: FDA seeks comments on a consulting firms assessment of the Prescription Drug User Fee Act Workload Adjust...

Comments Reopened on BE Assessment of Veterinary Drugs

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Federal Register Notice: FDA reopens the comment period on in vitro methods used to assess bioequivalence of nonsystemically absor...

ICH Guidance on Efficacy Component in CTD Format

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Federal Register Notice: FDA releases a draft ICH guidance: M4E(R2): The CTD Efficacy.

Amicus Delays Fabry Disease NDA Due to FDA Data Request

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Amicus Therapeutics delays its plans to submit an NDA by the end of the year for migalastat, indicated for treating Fabry disease,...

FTC Weighs in on Brand Drug Product Hopping

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An FTC brief to the Third Circuit Court of Appeals calls into question brand name drug makers product-hopping, whereby companies m...

Sandoz Files 2nd Biosimilar App for Amgen Drug

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FDA accepts a Sandoz BLA (351(k) pathway) for a proposed biosimilar to Amgens Enbrel (etanercept), indicated for treating a range ...

RegenxBio Rare Disease Therapy Wins Orphan Status

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FDA grants RegenxBio an orphan drug designation for RGX-111 for treating mucopolysaccharidosis Type 1.