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Generic Drug Approvals Set New Record

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The CDER Office of Generic Drugs sets a new record for generic drug approvals.

TransEnterix Gains Clearance for Smaller Surgery Instruments

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FDA clears a TransEnterix 510(k) clearance for 3 millimeter diameter instruments for its Senhance System for use in microlaparosco...

Boehringer sNDA for Broader Stiolto Respimat Label OKd

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FDA approves a Boehringer Ingelheim supplemental NDA for new labeling on its Stiolto Respimat (tiotropium bromide and olodaterol) ...

Safety Alert on Medtronic Cybersecurity Software Fix

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FDA issues a safety alert following a Medtronic software update to address a risk caused by cybersecurity vulnerabilities associat...

Ban Uncontained Power Morcellators: Petition

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Surgeon and anti-power morcellator activist Hooman Noorchashm petitions FDA to ban uncontained laparoscopic power morcellators use...

Webinar Explains Indication, Usage Guidance

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CDER special assistant for labeling Iris Masucci uses a Webinar to provide detailed information on a draft guidance on the content...

FDA $5 Million Grant to Spur Pediatric Device Development

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FDA awards $5 million to the National Capital Consortium for Pediatric Device Innovation, led by Children's National Health System...

FDA Renews Dermatologic/Ophthalmic Drugs Panel Charter

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Federal Register notice: FDA renews the charter of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two ...

FDA Clears Transseptal Solutions Access System

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FDA clears a Transseptal Solutions 510(k) for the TSP Crosser Transseptal Access System, a transseptal puncture system with a buil...

FDA Renews Charter for Antimicrobial Drugs Panel

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Federal Register notice: FDA renews for two years the charter of its Antimicrobial Drugs Advisory Committee.