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Add Dementia Boxed Warning to PPI Labeling: Petition

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The Alliance for Natural Health calls on FDA to require a Boxed Warning for proton pump inhibitors on the risk of dementia associa...

FDA Updates Device Covid FAQ

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FDA adds two updates to its Web page FAQs on Supplies of Medical Devices for Covid-19.

FDA De Novo Marketing for 4 Weight-Loss Devices

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FDA grants de novo marketing authorizations for Apollo Endosurgery and its Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REV...

CDC Recommends Use of Novavax Covid Vaccine

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The U.S. CDC Advisory Committee on Immunization Practices votes unanimously to recommend the use of the Novavax Covid-19 Vaccine, ...

CDRH Seeks Feedback on eSubmission Process

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CDRH seeks feedback on its new eSTAR and eCopy electronic submission process for 510(k) and De Novo device submissions.

Draft Guide on Vet Drug Residual Solvents

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Federal Register notice: FDA makes available a draft guidance #100 entitled Impurities: Residual Solvents in New Veterinary Medici...

Sanofi Scraps Phase 2 Study of Lademirsen

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Sanofi tells Regulus Therapeutics that it is terminating a Phase 2 clinical study (HERA Study) of lademirsen (RG-012) for treating...

Acer Refiles NDA for Urea Disorder Drug

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Acer Therapeutics resubmits its NDA for ACER-001 (sodium phenylbutyrate) for oral suspension for treating patients with urea cycle...

New CDISC Versions Support and Use Dates Announced

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Federal Register notice: FDA announces the date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Stan...

Acadia Pharmaceuticals NDA for Rett Syndrome

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Acadia Pharmaceuticals files an NDA for trofinetide for treating Rett syndrome in adults and pediatric patients two years of age a...