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Comments Extended on Device Remanufacturing Guide

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Federal Register notice: FDA extends the comment period for a 6/24 notice on a draft guidance entitled Remanufacturing of Medical ...

FDA Joins More Device Collaborative Communities

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FDA says it has joined several additional medical device collaborative communities.

PharmaTher Orphan Status for Ketamine in ALS

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FDA grants PharmaTher Holdings an orphan drug designation for ketamine and its use in treating amyotrophic lateral sclerosis.

Bloomberg Urges More FDA Transparency on Covid Vaccine

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The Bloomberg editorial board calls on FDA to communicate transparently on the timing for final approval of Covid-19 vaccines that...

7 Observations on Lilly FDA-483

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FDA releases the FDA-483 with seven observations from an inspection at a Lilly sterile drug manufacturing facility.

FDA Posts 506J Notification Submission Q&A

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FDA posts a Web page with answers to common questions on medical device online 506J notification submission methods during the Cov...

Arriva Medical (Alere) Paying $160 Million on False Claims Charges

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The Justice Department says Alere and its Arriva subsidiary are paying $160 million to resolve False Claims Act charges first brou...

Istodax Indication Withdrawn After Confirmatory Trial

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Bristol Myers Squibb decides to withdraw a 2011 indication granted to subsidiary Celgene under accelerated approval for Istodax (r...

Multiple Violations at Farmakeio Outsourcing

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FDA warns Farmakeio Outsourcing about violations at its Texas drug facility.

FDA Accepts Tecentriq sBLA for Priority Review

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FDA accepts a Genentech sBLA for a new indication for Tecentriq and grants it priority review.