FDA seeks public comment on a proposed Potential Tobacco Product Violations Reporting Form; 60-day comment period required under the Paperwork Reduction Act of 1995.
FDA withdraws approval of Epizyme's TAZVERIK (tazemetostat) 200mg tablet following the company's voluntary request for NDA withdrawal.
FDA classifies simple in vitro diagnostic devices for detecting Bacillus species secreted proteins in human clinical samples as Class II medical devices with special controls.
FDA classifies endoscopic light-projecting measuring devices as class II medical devices subject to special controls for gastroenterology-urology applications.
FDA classifies endoscopic traction devices as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burdens for manufacturers.
MorningStar Farms voluntarily recalls Buffalo Chik'n Nuggets and Hot & Spicy Sausage products in the U.S., Puerto Rico, and Costa Rica due to possible plastic contamination.
Clover Hill Dairy of Mechanicsville, Maryland recalls all Clover Hill Dairy brand cheese due to potential Listeria monocytogenes contamination; recall effective June 18, 2026.
FDA withdraws approval of SpecGx LLC's abbreviated new drug application for Methylphenidate Hydrochloride Extended-Release tablets in 27mg, 36mg, and 54mg strengths per the applicant's request.
The FDA renews its Science Board advisory committee for an additional two years, with the new charter expiring June 26, 2028.
FDA requests OMB clearance for information collection activities related to Current Good Manufacturing Practice regulations for Type A medicated articles and medicated feeds under the Paperwork Reduction Act of 1995.
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