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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...

FDA Reclassifies/Renames Female Condom

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Federal Register notice: FDA proposes to reclassify single-use female condoms, renaming the device to single-use internal condom, ...

Guide on IDE Categorization for CMS Coverage Decisions

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FDA issues a guidance on FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare a...

Pharmaceutical Site Visit Program Seeks Proposals

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Federal Register notice: CDER announces its intent to accept proposals from pharmaceutical companies interested in participating i...

Gottlieb to Meet with Lawmakers on Essure Concerns

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FDA commissioner Scott Gottlieb agrees to meet with Rep. Rosa DeLauro (D-CT) and other members of Congress to discuss the safety o...

Amgen sBLA Approved for Cardiovascular Risk Reduction

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FDA approves an Amgen supplemental BLA for Repatha (evolocumab) for preventing heart attacks, strokes and coronary revascularizati...

FDA Approves Lillys Taltz for Psoriatic Arthritis

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FDA approves Eli Lillys Taltz (ixekizumab) injection 80 mg/mL for treating adults with active psoriatic arthritis.