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Reps Reiterate Call for VALID Act Passage

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Reps. Bucshon and DeGette call on Congress to pass the VALID Act in response to FDAs proposed rule on laboratory-developed tests.

Invitae Gets De Novo for Hereditary Cancer Panel

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FDA grants Invitae a de novo market authorization for its Common Hereditary Cancers Panel for identifying germline variants associ...

Panel on Blood Irradiator Into Class 3

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Federal Register notice: FDA is announcing an 11/7 Radiological Devices Panel of the Medical Devices Advisory Committee meeting to...

11 Covid-19 Product EUAs Revoked

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Federal Register notice: FDA announces the revocation of 11 Covid-related Emergency Use Authorizations after the authorization hol...

Stimulant Use Disorder Drug Development Guide

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Federal Register notice: FDA releases a draft guidance entitled Stimulant Use Disorders: Developing Drugs for Treatment.

FDA Looking Into Counterfeit Ozempic: Report

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CBS News says a drug supply chain association issued an alert that FDA is investigating counterfeit Ozempic.

NextGen Portal Accepts OTC Monograph Files

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CDER says its NextGen Portal is now accepting Over-the-Counter Monograph Order Requests.

Coherus Refiles Udenyca Onbody BLA Supplement

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Coherus BioSciences resubmits a BLA supplement for Udenyca Onbody, the company's on-body injector presentation of Udenyca (pegfilg...

AstraZeneca Comments on FDA QTc Draft Guidance

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AstraZeneca suggests several things FDA could add to a draft guidance on QTc information in drug and biologic labeling.

Reagan-Udall Strategies to Understand Regulated Products

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The Reagan-Udall Foundation publishes a report with strategies for FDA to consider to improve public understanding of FDA and its ...