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Appeals Court Affirms Dismissal of FOIA Case

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The 2nd Circuit Court of Appeals says a New York federal court properly granted summary judgment to FDA and Sarepta in a Freedom o...

FDA Says Haimen Shengbang Container Recall Class 1

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FDA says the Haimen Shengbang Laboratory Equipment recall of unapproved viral transport media containers is Class 1.

European Data Privacy Law Affects FDA: Attorney

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FDA attorney Heather Messick describes agency concerns with the European Union's General Data Protection Regulation.

Attralus Gets Orphan Status for Imaging Agent

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FDA grants Attralus an orphan drug designation for 124 I-AT-01 iodine (evuzamitide) as a diagnostic for managing transthyretin amy...

Myfembree Wins OK for Endometriosis Pain

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FDA approves Myovant Sciences/Pfizers Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing m...

Info Collection on Device Q-Submissions

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Federal Register notice: FDA seeks comments on an information collection revision entitled "Q-Submissions Program for Medical Devi...

Panel to Discuss Rebiotix BLA

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Federal Register notice: FDA announces a 9/22 Advisory Committee meeting to review a Rebiotix BLA for Rebyota (fecal microbiota, l...

Reata Faces FDA Efficacy Scrutiny on Omaveloxolone

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FDA raises efficacy concerns about Reata Pharmaceticals May-submitted NDA for omaveloxolone, indicated for treating patients with ...

Appeals Court Overturns Preemption-related Dismissal

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A federal appeals court overturns a district court decision to dismiss, due to federal preemption, product liability claims under ...

Nominations Sought for Device Panels

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Federal Register notice: FDA seeks nominations for voting members to serve on CDRHs Medical Devices Advisory Committee device pane...