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Botox Gains Expanded Use in Pediatric Spasticity

[ Price : $8.95]

FDA approves an Allergan supplemental BLA for an expanded use for Botox (onabotulinumtoxinA) treating spasticity in pediatric pat...

FDA Clears Auto-Contouring Software

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FDA clears a Mim Software 510(k) for its deep learning auto-contouring software, Contour ProtgAI.

Draft Guide on Peripheral Vascular Atherectomy Devices

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FDA makes available a draft guidance entitled Select Updates for Peripheral Vascular Atherectomy Devices -Premarket Notification [...

Consumer Organizations Sought for Advisory Panel Selections

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Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting or nonvoting consumer re...

Baxter Bone Graft Cleared

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FDA clears a Baxter International 510(k) for the AltaporeShape Bioactive Bone Graft, which is intended to enhance bone growth and ...

Info Collection on Opioid Abuse Deterrent Formulations

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Federal Register notice: FDA sends to OMB a new information collection entitled Health Care Providers Understanding of Opioid Anal...

Info Collection on Social Behavioral Sciences Data

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Federal Register notice: FDA seeks comments on a new information collection for data to support cross-center collaboration for soc...

New Study on Disclosures in Drug Ads

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Federal Register notice: FDA seeks comments on a new information collection entitled Examination of Secondary Claim Disclosures an...

Comments on AI in Radiological Imaging

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Two stakeholders comment to FDA on the agencys public workshop on the evolution of artificial intelligence in radiological imaging...

WLF Wants Access to PGx Information

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Washington Legal Foundation supports a petition seeking to block FDA from suppressing the dissemination of pharmacogenomics data.