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FDA Releases Action Plan on Demographic Trial Data

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Federal Register Notice: FDA makes available for comments an action plan as required by the the Food and Drug Administration Safet...

Guidance on Device Study Sex-Specific Data

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Federal Register Notice: FDA releases a guidance: Evaluation of Sex-Specific Data in Medical Device Clinical Studies.

Workshop Planned on Contact Lens Disinfection

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Federal Register Notice: FDA will co-sponsor a public workshop 9/12 entitled Revamping Microbiological Test Methods for Contact Le...

FDA Proposes to Remove General Safety Test for Biologics

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Federal Register Proposed rule: FDA proposes to amend the biologics regulations by removing the general safety test requirements f...

FDA Clears Arthrosurface Bunion Suture System

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FDA clears an Arthrosurface 510(k) for the KISSloc Suture System, a mini plate and suture implant intended for correcting a Hallux...

FDA Clears Firefly Imaging for da Vinci Surgical System

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FDA clears Intuitive Surgicals Firefly Fluorescence Imaging for the da Vinci Xi Surgical System to provide enhanced visualization ...

FDA Discusses Its Work Against Ebola Outbreak

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FDA discusses its efforts to help combat the Ebola virus outbreak in West Africa.

FDA Cutting Duplicative Biologics Safety Test Requirements

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FDA proposes to remove the general safety test requirements for biological products from regulations because they are duplicative ...

More Boxed Warning Research Needed: Blog

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Health Affairs bloggers Aaron Kesselheim and Lara Maggs say more research into Boxed Warnings is needed if they are to remain a us...

FDA Extends UDI Compliance Date for Eye Lens Makers

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CDRH grants Class 3 intraocular and contact lens manufacturers a one-year compliance extension for meeting requirements under its ...