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Medical Devices

FDA Says Haimen Shengbang Container Recall Class 1

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

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Human Drugs

European Data Privacy Law Affects FDA: Attorney

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

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Federal Register

Info Collection on Device Q-Submissions

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

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Federal Register

Panel to Discuss Rebiotix BLA

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

Human Drugs

Reata Faces FDA Efficacy Scrutiny on Omaveloxolone

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

Medical Devices

Appeals Court Overturns Preemption-related Dismissal

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

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Human Drugs

Attralus Gets Orphan Status for Imaging Agent

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

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Human Drugs

Myfembree Wins OK for Endometriosis Pain

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

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Human Drugs

FDA Guide to Streamline Cancer Trial Eligibility Efforts

A JAMA Oncology article discusses a collaboration between FDA, the National Cancer Institute, and patient and industry representatives that has develo...

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Human Drugs

Enhertu Approved for HER2-low Breast Cancer

FDA approves a Daiichi Sankyos Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for treating patients with unresectable or metastatic HER2-lo...