April 16, 2026 · Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for UNLOXCYT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission...
June 23, 2026 · Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
June 22, 2026 · Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II (special controls). The special...
June 22, 2026 · Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of...
June 22, 2026 · Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is classifying the endoscopic traction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified...
June 13, 2026 · FDA
Nara Organics of New York, NY, is voluntarily recalling all lots of Nara Organics Powdered Infant Formula currently on the market out of an abundance of caution due to the potential risk of Clostridium botulinum contamination.
Infant...
May 15, 2026 · Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Oscar Bobo for a period of 5 years from importing or offering for import any drug into the United...
May 8, 2026 · FDA
The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting to study the safety of...