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China Made Alcohol Prep Pads Recalled

[ Price : $8.95]

Simple Diagnostics recalls three lots of Pharmacist Choice Alcohol Prep Pads, which were manufactured by China-based Foshan Flying...

General, Specific Comments on Analytical Similarity Guidance

[ Price : $8.95]

Stakeholders give FDA general and specific comments on a draft guidance on statistical approaches to evaluating analytical similar...

Dont Approve Evolus Neurotoxin BLA: Medytox

[ Price : $8.95]

Medytox asks FDA not to approve an Evolus BLA for a neurotoxin product manufactured by Daewoong until the agency verifies the toxi...

EU Vow to End Dental Amalgam Use by 2022

[ Price : $8.95]

European activists vow to end all dental amalgam use in the EU by 2022, in sharp contrast to FDAs continued defense of the device....

Guidance on 3D Printing Technical Considerations

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Federal Register notice: FDA makes available a guidance on Technical Considerations for Additive Manufactured Medical Devices that...

Guide on IDE Categorization for CMS Coverage Decisions

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Federal Register notice: FDA makes available a guidance entitled FDA Categorization of Investigational Device Exemption Devices to...

FDA Again Pushing Uniform National Regulation: Attorney

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A Washington Legal Foundation online Legal Pulse praises FDA for again promoting uniform national regulation through appearances i...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Hangzhou Facecare Cosmetics Co., Hand Biomechanics Lab, and PharmSc...

Additions to Device Consensus Standards

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Federal Register notice: FDA announces six modifications the agency is making to its FDA-Recognized Consensus Standards listing fo...

FDA Guidance on 3-D Printing Plans for Future Innovations

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FDA issues a new guidance on Technical Considerations for Additive Manufactured Medical Devices 3D Printing of Medical Devices tha...