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Guidance on Plasma Fibrinogen Biomarker Qualification

[ Price : $8.95]

Federal Register notice: FDA posts a guidance on Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations ...

CDER Plans New Guidances on Combos, Quality Metrics

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CDER says it will develop a guidance this year on Comparative Analyses of the Device Constituent of a Drug-Device Combination Prod...

FDA Guidance on Cell/Tissue Donor Testing

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FDA posts a guidance on Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Huma...

Novocure Reports Favorable Long-term Data with Optune System

[ Price : $8.95]

Novocure says a long-term survival analysis of data from a Phase 3 (EF-14) trial of Optune in combination with temozolomide confir...

DC Court Rules Against FDA in 5-year Exclusivity Decisions

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The Washington DC District Court rules against FDA in granting a Ferring motion for reconsideration over how FDA decided not to re...

FDA Lists OMB Information Collection Approvals

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Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budge...

Guidance on 510(k) Third-party Reviews

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Federal Register notice: FDA releases a draft guidance on 510(k) Third Party Review Program.

FDA Seeks Tobacco Scientific Committee Nominations

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Federal Register notice: FDA seeks nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee.

FDAers Query Chantix Study that Seeks Boxed Warning Removal

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FDA reviewers see concerns with the ascertainment of the primary neuropsychiatric adverse event outcome that impacts interpretatio...

Swallowable Weight-loss Balloon Approved by FDA

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FDA approves an Obalon Therapeutics PMA for the Obalon Balloon System, a nonsurgical, reversible device for weight loss.