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Medical Device, Drug Recalls Drop in Q2: Sedgwick

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The Segwick Recall Index shows that both medical device and drug recalls dropped in the second quarter of 2023 from the first quar...

Orphan Status for Biliary Tract Cancer Drug

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FDA grants Nuvectis Pharmas NXP800 an orphan drug designation for treating biliary tract cancer.

Pentax Endoscope and Video Processor Cleared

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FDA clears a Pentax Medical 510(k) for its Inspira 4K video processor and the i20c video endoscope.

FDA Oks Ipsens Sohonos for FOP

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FDA approves Ipsens Sohonos as the first treatment for adults and some pediatric patients with fibrodysplasia ossificans progressi...

Cardiosave Balloon Pump Recall Class 1: FDA

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FDA says the Datascope/Maquet/Getinge recall of Cardiosave balloon pumps is Class 1.

BlueWind De Novo for Incontinence Device

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FDA grants BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for tr...

Workshop on Postapproval Pregnancy Studies

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Federal Register notice: FDA announces a 9/18-19 public workshop entitled Optimizing the Use of Postapproval Pregnancy Safety Stud...

Vanda Pushes Back on Hetlioz sNDA Hearing Denial

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A sharply-worded Vanda response to FDA says commissioner Robert Califf should reject a CDER proposed order and either approve Vand...

FDAs Lighter Enforcement May be Ending: Attorney

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Attorney Douglas Farquhar says an FDA trend toward more enforcement discretion for drug company inspections with official action i...