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GDUFA Division Level Reconsideration Request

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FDA publishes a guidance reflecting GDUFA 3 provisions on the procedures for ANDA applicants to follow in requesting reconsiderati...

FDA Clears Medical AI Imaging Software

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FDA clears a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered software AiMify for brain MRIs...

Novocures Optune Lua for Lung Cancer OKd

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Novocure wins PMA approval for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for treating adult patients w...

Court Tosses Novartis Entresto Suit Against FDA

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The DC federal court rules in favor of FDA and MSN Pharmaceuticals as defendants in a suit filed by Novartis over the agencys appr...

FDA on Curbing X-ray Device Interference

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FDA makes recommendations to prevent damage to wearable medical devices from X-ray imaging, including CT scans.

CGMP Violations at Outin Futures

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FDA warns Koreas Outin Futures Corp. about CGMP and misbranding violations at its drug manufacturing facility.

Noxafil Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not wit...

IntraBio Wins Priority Voucher for Aqneursa Approval

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Federal Register notice: FDA issues IntraBio a priority review voucher after determining its recent approval of Aqneursa (levacety...

14 Observations in Qualgen FDA-483

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FDA releases the form FDA-483 with 14 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing faci...

FDA Clears AI-Interpreting Echocardiography Software

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FDA clears an iCardio.ai 510(k) for its artificial intelligence software EchoMeasure for interpreting echocardiography.