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Minor Updates to 2 Magnetic Resonance Guidances

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FDA publishes minor updates to two magnetic resonance guidances to harmonize them with the latest consensus standards.

Researcher Cited for Objectionable Conditions

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FDA warns Miami, FL-based Dr. Antonio Blanco/Vista Health Research about conducting two clinical investigations in a way that did ...

FDA Cautions About Compounded Ketamine

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FDA lists several cautions it says patients and healthcare providers should be aware of when considering using compounded ketamine...

FDA QTc Draft Guidance Too Vague: NCHR

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The National Center for Health Research says an FDA draft guidance on QTc information in drug and biologic labeling is too vague t...

CDRH Plans 24 Guidances in FY 2024

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CDRH publishes a list of final and draft guidances to be published in FY 2024.

FDA Diversity Plan Draft Guidance Due: RAPS

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A RAPS publication says FDA is likely to publish a draft guidance on plans for clinical trial diversity by the end of this year.

Hyperfines AI Brain Imaging Software Cleared

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FDA clears a Hyperfine 510(k) for updated software for its portable magnetic resonance brain imaging system, the Swoop system.

Guide on Magnetic Resonance Diagnostics

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FDA posts a final guidance entitled Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.

FDA OKs Medtronics Next-Gen SynchroMed

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FDA approves Medtronics next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pai...

Positive Keytruda Data in Lung Cancer: Merck

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Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients wit...