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Diversity in Trials Final Guidance

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Federal Register notice: FDA makes available a final guidance entitled Enhancing the Diversity of Clinical Trial Populations Elig...

Supernus Talking with FDA on Two Submissions

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Supernus Pharmaceuticals says it has received a complete response letter and refusal to file letter from FDA for two NDAs and will...

OPDP Revising Drug Promo Core Launch Reviews

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CDER Office of Prescription Drug Promotion acting director Catherine Gray says that beginning next year the Office is revising its...

Stryker Trevo XP ProVue Retriever Recall is Class 1

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FDA says the Stryker Neurovascular recall of its Trevo XP ProVue Retriever due to a core wire that may break or separate during us...

CDER Finds Ways to Streamline Schizophrenia Drug Trials

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CDER researchers say it may be possible to streamline clinical trials for drugs to treat schizophrenia by cutting the trial length...

Comments Extended on Animal Drug Special Programs

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Federal Register notice: FDA extends the comment period on a 7/15 notice about a draft guidance #61 entitled Special Consideration...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Nartex Laboratorios Homeopaticos.

Pfizer/BioNTech Covid Vaccine 90% Effective Vaccine: Early Data

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Pfizer and BioNTech report data from an interim efficacy analysis showing that their Covid-19 vaccine is more than 90% effective i...

Panel Thumbs Down on Biogen Alzheimers Drug

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FDAs Peripheral and Central Nervous System Drugs Advisory Committee votes not to recommend approval of Biogens Alzheimers drug adu...

Former FDA Head Kessler Co-chairs Biden Covid Advisors

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President-elect Joe Bidens transition team announces the formation of the Transition Covid-19 Advisory Board, which is co-chaired ...