Learn more about FDA’s Postmarketing Requirements and Commitments Searchable Database.
Similar Posts
FDA Clinical Trials Training Modules
This training represents regulatory intelligence that sets global standards for clinical research. The content reflects current FDA thinking, emerging guidance, and real-world regulatory experience, providing participants with the most reliable and up-to-date information available.Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings
Draeger recalls SafeStar, TwinStar filters due to misleading carbon dioxide waveforms, may result in unnecessary treatment, potentially causing harm or deathFDA approves taletrectinib for ROS1-positive non-small cell lung cancer
On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).Best Buy Bones, Inc. Recalls Nature’s Own Pet Chews Bully Bites Because of Possible Salmonella Health Risk
October 3, 2025, Best Buy Bones, Inc. of Mount Morris, Michigan is recalling four lots of Nature’s Own Pet Chews Bully Bites 1 Pound pet treats in 16 oz. bags with a shared expiration date of September 2027because it has the potential to be contaminated with Salmonella. Salmonella can affect animalsBiosimilars Guidances
This page lists Biosimilars Guidance documents.Over-The-Counter Monograph Drug User Fee Program (OMUFA)
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.