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FDA Approves Medtronic Simplera Monitor

[ Price : $8.95]

FDA approves Medtronics Simplera disposable continuous glucose monitor.

FDA accepts Cabometyx sNDA for Pancreatic Tumors

[ Price : $8.95]

FDA accepts for review an Exelixis supplemental NDA for Cabometyx (cabozantinib) and its use for treating certain adults with panc...

CDRH Health Equity Discussion Paper

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CDRH publishes a discussion paper to seek public feedback on the issue of health equity in the context of medical devices.

Bill Introduced to Spur Pediatric Rare Disease Studies

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Senators Jack Reed (D-RI) and Shelley Moore Capito (R-WV) introduce a bipartisan bill entitled Innovation in Pediatric Drugs Act (...

Smiths Medical Software Correction for Infusion Pumps

[ Price : $8.95]

Smiths Medical corrects software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may o...

Loper Bright May End FDA Speech Ban: Attorney

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Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new...

Medtronic Recalls Nerve Monitor

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Medtronic recalls (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative...

Velocity Marketed Adulterated Eye Drops: FDA

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FDA warns Melville, NY-based Velocity Pharma that it has received and distributed adulterated eye drop products produced for it by...

CGMP Violations at Guangzhou Baiyunshan

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FDA warns Chinas Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. about CGMP violations in its production of finished drug...

Enhancing Diversity in Pediatric Drug Development Workshop

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Federal Register notice: FDA announces a 9/6 public workshop entitled Enhancing Diversity in Therapeutics Development for Pediatri...