FDA publishes six-month summary statistics for drug development tool qualification projects.
FDA says healthcare professionals should discuss naloxone with patients taking opioid pain medicines or drugs for opioid use disorder and consider pre...
Fresenius Kabi recalls two lots of dexmedetomidine HCl in 0.9% sodium chloride injection due to the possibility of a trace amount of lidocaine present...
FDA and the Federal Trade Commission says Create Wellness Clinics is marketing several types of unapproved products intended to treat Covid-19.
Internet of Things (IoT) security firm Ordr says many IoT medical devices have been subject to FDA recall as defective or risky.
U.S. senators Mike Enzi (R-WY) and Maggie Hassan (D-NH) introduce legislation that would help protect patients from counterfeit medical products that ...
Federal Register notice: FDA publishes an order to exempt a list of Class 2 devices from 510(k) requirements, subject to certain limitations.
Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Bas...