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Comments on OPDP Quantitative Claims Research

[ Price : $8.95]

Two stakeholders raise questions about proposed Office of Prescription Drug Promotion research into quantitative claims in direct-...

FDA Reiterates NuVasive Device Indications

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FDA reiterates the indication and instructions for use of the NuVasive Specialized Orthopedics Precice Intramedullary Limb Lengthe...

Candela Laser Cleared for Capillary Malformations

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FDA clears a Candela 510(k) to expand the labeled indication of its Vbeam Pulsed Dye Laser for use of the 595 nm wavelength to inc...

Overject AI Technology for Dental Caries Cleared

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FDA clears an Overjet 510(k) to expand the use of its artificial intelligence technology for predicting tooth decay in younger pat...

Pfizer/OPKO Pediatric Growth Hormone OKd

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FDA approves a Pfizer and OPKO Health BLA for Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for t...

Eton Pharma Gets Complete Response Letter

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FDA sends Eton Pharmaceuticals a second complete response letter on its NDA for dehydrated alcohol injection for treating methanol...

Compounded Drug Wholesaling Prohibition Guide

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Federal Register notice: FDA makes available a draft guidance entitled Prohibition on Wholesaling Under Section 503B of the Federa...

4 Observations in Prisma Health FDA-483

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FDA releases the form FDA-483 with four observations issued following an inspection at the Prisma Health outsourcing facility in S...

Guide on Quantitative Data in DTC Materials

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Federal Register notice: FDA makes available a final guidance entitled Presenting Quantitative Efficacy and Risk Information in Di...

FDA Bars Chengdu KeCheng Drugs

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FDA issues an Import Alert against all drugs from Chinas Chengdu KeCheng Fine Chemicals and a Warning Letter about its continuing ...