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FDA Expands Device Early Alert Program

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FDA expands its medical device Early Alert program to cover all products that may pose significant safety risks.

FDA Presses for Clinical Trial Reporting Compliance

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CDER director George Tidmarsh urges more compliance with clinical trial reporting requirements through the Clinicaltrials.gov gate...

AbbVie Files NDA for Parkinsons Drug Tavapadon

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AbbVie files an NDA for tavapadon, an investigational once-daily oral therapy for Parkinsons disease.

Eyeglass Lenses OK'd for Pediatric Nearsightedness

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FDA grants Essilor a de novo marketing authorization for its Stellest eyeglass lenses, which are designed to both correct vision a...

FDA Approves New Drug for Acromegaly

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FDA approves a Crinetics NDA for Palsonify (paltusotine) for treating adults with acromegaly who have had an inadequate response t...

FDA Rebukes Novartis Over Misleading TV Ad

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FDA sends Novartis Pharmaceuticals an untitled letter citing the companys allegedly false or misleading direct-to-consumer televis...

Capricor Gets FDA OK on Duchenne BLA Refiling

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Capricor Therapeutics reaches agreement with FDA on the design and role of its HOPE-3 trial as it works to resubmit its BLA for De...

Hansa Biopharmas Imlifidase Hits Primary Endpoint

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Hansa Biopharma says imlifidase met the primary endpoint in a pivotal Phase 3 study in kidney transplant patients.

FDA NextGen Submission Portal Guide

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FDA publishes a guide to its Electronic Submission Gateway NextGen Unified Submission Portal.

Public Confidence in FDA, Others Dropping: Survey

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The latest University of Pennsylvania Annenberg Public Policy Center survey documents a significant drop since last fall in the pe...