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FDA Budget Looks at Data Modernization, Enhanced Technologies

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FDA acting commissioner Janet Woodcock says the agency FY 2022 budget request envisions significant efforts at data modernization ...

Court Says FDA Cant Ban Electrical Stimulation for One Purpose

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The DC Court of Appeals says FDA cannot ban the use of electrical stimulation devices to treat aggressive or self-injurious behavi...

CDER Protein Therapeutics Director Joins EpiVax

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CDER Division of Therapeutic Proteins director Amy Rosenberg leaves the agency to join EpiVax as senior director of immunology and...

FDA Urged to Do More for Patient-Focused Drug Development

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A report on FDAs use of patient-focused drug development calls on the agency to do more to promote such development.

FDA Says Aquavit Pharmaceuticals Marketing Unapproved Devices

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FDA warns Aquavit Pharmaceuticals it is marketing unapproved medical devices.

FDA WEBVIEW CLOSED JULY 4TH WEEK

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In observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Tuesday, ...

Draft Guide on Cancer Trial Eligibility Criteria

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Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Approach to Ava...

FDA Delays Decisions on Rinvoq Supplemental NDAs

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FDA delays the review actions on two AbbVie supplemental NDAs for Rinvoq (upadacitinib), a JAK inhibitor for treating adults with ...

Guide on Drug Study Safety Reporting Requirements

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FDA posts a draft guidance on Sponsor Responsibilities Safety Reporting Requirements and Safety Assessment for IND and Bioavailab...

Info Collection on HIV Test Special Controls

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Federal Register notice: FDA seeks comments on a proposed information collection entitled Class II Special Controls for Human Imm...