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Federal Register notice: FDA releases a draft guidance on 510(k) Third Party Review Program.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

FDA Orphan Status for BioVie Ascites Therapy

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FDA grants BioVie an orphan drug designation for BIV201 for treating ascites due to all causes except cancer.

FDA Clears GE MAGiC MRI Technology

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GE Healthcare gains 510(k) clearance for MAGiC (Magnetic Resonance Image Compilation), which is a customized version of SyntheticM...

FDA Draft Guide on 510(k) 3rd-party Reviews

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FDA posts a draft guidance on 510(k) Third Party Review Program that describes harmonization efforts, such as incorporating elemen...

FDA Posts Inspection Report Involving Theranos Test

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FDA posts a one-page Form-483 from an inspection last month at troubled blood diagnostic firm Theranos.