FDA publishes minor updates to two magnetic resonance guidances to harmonize them with the latest consensus standards.
FDA warns Miami, FL-based Dr. Antonio Blanco/Vista Health Research about conducting two clinical investigations in a way that did not follow the inves...
FDA lists several cautions it says patients and healthcare providers should be aware of when considering using compounded ketamine products to treat c...
The National Center for Health Research says an FDA draft guidance on QTc information in drug and biologic labeling is too vague to be useful and reco...
CDRH publishes a list of final and draft guidances to be published in FY 2024.
A RAPS publication says FDA is likely to publish a draft guidance on plans for clinical trial diversity by the end of this year.
FDA clears a Hyperfine 510(k) for updated software for its portable magnetic resonance brain imaging system, the Swoop system.
FDA posts a final guidance entitled Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
