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Update GAO Device Recall Oversight Report: Senators

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Sens. Durbin and Blumenthal ask the Government Accountability Office to update its 2011 report on FDA oversight of medical device ...

Novid Distributing Unapproved, Misbranded Drug: FDA

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FDA warns Northridge, CA-based Novid Group that it is illegally distributing an unapproved and misbranded over-the-counter antihis...

Vertex Moving Neuropathy Pain Drug to Phase 3

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Vertex Pharmaceuticals says it will advance selective NaV1.8 inhibitor VX-548 into pivotal Phase 3 studies based on positive resul...

Guide on Advanced Manufacturing Tech

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Federal Register notice: FDA makes available a draft guidance entitled Advanced Manufacturing Technologies Designation Program.

Genetic Metabolic Disease Panel Established

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Federal Register notice: FDA creates the Genetic Metabolic Diseases Advisory Committee to review and make recommendations on inves...

Regulatory Affairs, Foods Program Under Review

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FDA says HHS has started reviewing the agencys proposed reorganization for a unified Human Foods Program and a revised Office of R...

HELP Committee OKs EFFECTIVE Opioid Bill

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The Senate HELP Committee passes legislation giving FDA additional authority to deny opioid analgesic NDAs.

GOP Senators Urge Increase in Foreign Inspections

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Nine Republican senators press FDA to increase its foreign inspections of medical product manufacturing facilities.

Amgen Files Priority BLA for Lung Cancer

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FDA accepts for priority review an Amgen BLA for tarlatamab for treating certain adult patients with advanced small cell lung canc...

AdvaMed Faults FDA on Safety 510(k) Guidances

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AdvaMed faults FDA for not approving an extension to the comment deadline on three 510(k) guidances issued in September concerning...