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Trade Groups Comment on Externally Controlled Trials

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Two major drug trade associations comment on an FDA draft guidance on external controls in drug and biologic clinical trials.

Nano-X Imaging Gets Clearance for New X-ray

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FDA clears a Nano-X Imaging 510(k) for its Nanox ARC, a stationary X-ray system intended to produce tomographic images of the huma...

Smart Heart Toilet Seat Cleared by FDA

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FDA clears a Casana 510(k) for the Heart Seat, a smart toilet seat for measuring heart rate and oxygen saturation.

Members of Congress Seek Mifepristone Reversal

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More than 250 Democrat members of the House and Senate petition the 5th Circuit Court of Appeals to overturn a Texas federal court...

Industry Offers Input on AI in Drug Manufacturing

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Pharmaceutical Research and Manufacturers of America tells FDA artificial intelligence offers many opportunities for manufacturers...

Accelerated Approval Withdrawals Likely to Increase: Attorneys

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Two SheppardMullin attorneys say that drug manufacturers seeking accelerated approval should be aware that 10% of drugs approved t...

CGMP Violations in Voyant Beauty Inspection

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FDA warns Elkhart, Indiana-based Voyant Beauty about CGMP and other violations in its work as a drug contract manufacturer.

Decentralized Clinical Trial Recommendations

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FDA says a new draft guidance will help sponsors and investigators broaden and diversify clinical trial participation through usin...

DirectSync Gets Breakthrough on Spinal Fusion Device

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FDA awards DirectSync Surgical a breakthrough device designation for its patient-powered smart spinal fusion device.

Vanda Says FDA Disclosed Trade Secrets to Competitors

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Vanda asks the U.S. Court of Federal Claims to rule that FDA deliberately released confidential commercial information and trade s...