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New FDA Convalescent Plasma Guidance

[ Price : $8.95]

FDA issues a new guidance with recommendations on using Covid-19 convalescent plasma under either an emergency use authorization o...

FDA, Polynoma Agree on Study for Melanoma Vaccine

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FDA and Polynoma reach agreement under a Special Protocol Assessment on a pivotal Phase 3 clinical trial of the companys melanoma ...

FDA Approves Cochlear Implants for Wider Deafness

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FDA has approved a Cochlear Limited PMA for its Cochlear Nucleus Implants for treating unilateral hearing loss and single-sided de...

Not the Time to Look at New Covid Approaches: Woodcock

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FDA acting commissioner Janet Woodcock tells a Senate Health, Education, Labor & Pensions hearing that the current omicron variant...

FDA OKs Idorsia Insomnia Drug

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FDA approves an Idorsia Pharmaceuticals NDA for Quviviq (daridorexant) 25 mg and 50 mg for treating adult patients with insomnia.

Drug Supply Chain Security Info Collection

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Federal Register notice: FDA sends to OMB an information collection revision entitled Drug Supply Chain Security Act Implementatio...

Guide on Device Supply Discontinuance/Interruption

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FDA posts a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...

Allogene Therapeutics Clinical Hold Removed

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FDA removes a clinical hold on Allogene Therapeutics AlloCAR T clinical trials after a chromosomal abnormality was determined to b...

Cardiovascular Systems Recall Wirion Device

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Cardiovascular Systems recalls its Wirion system due to complaints about filter breakage during retrieval.

Fast Track for Retinal Therapy

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FDA grants 4D Molecular Therapeutics a fast track designation for 4D-125 for treating patients with inherited retinal dystrophies ...