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Guides on Bioequivalence Study Designs

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Federal Register notice: FDA makes available a final guidance entitled M13A Bioequivalence for Immediate-Release Solid Oral Dosage...

FDA: Compounders Should Use Suitable Ingredients

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FDA reminds drug compounders to only use ingredients that are suitable for compounding drugs intended to be sterile.

FDA Extends Some Baxter Parenteral Drug Product Use Dates

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FDA announces extended use dates for some Baxter parenteral products to ease supply issues caused when a Baxter North Carolina fac...

Warning on Skin-Cap Spray Products

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FDA warns that Chemigroup France is marketing Skin-Cap aerosol spray products that may contain undisclosed steroids.

Exactech 3D-Printed Knee Implant Cleared

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FDA clears an Exactech 510(k) for the Truliant Porous Tibial Tray, a 3D-printed tibial knee implant.

Imbed Bio Lidocaine Wound Dressing Cleared

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FDA clears an Imbed Biosciences 510(k) for its Microlyte Ag/Lidocaine, an antimicrobial wound dressing that integrates lidocaine f...

Use Risk-Based AI/ML Regulation: AstraZeneca

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AstraZeneca provides four comments to the FDA docket on considerations for generative artificial intelligence/machine learning ove...

Datex-Ohmeda Recalls Giraffe OmniBeds

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GE HealthCare subsidiary Datex-Ohmeda recalls its Giraffe OmniBed and Giraffe OmniBed CareStation to update their use instructions...

UCBs Bepranemab Misses Primary Endpoint

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UCB says its investigational Alzheimers drug bepranemab missed the primary endpoint in a Phase 2a trial but hit secondary endpoint...

Verastem Oncology NDA for Rare Ovarian Cancer

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Verastem Oncology completes a rolling NDA submission for the combination of avutometinib and defactinib for adults with recurrent ...