Articles and Blogs

In August 2023, the U.S. Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023. To support trading partners in meeting these requirements, FDA implemented... READ MORE

In April 2024, the U.S. Food and Drug Administration (“FDA”) issued revised draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” (the “Draft Guidance”) intended to address common questions that arise during the process of developing promotional communications for prescription reference products... READ MORE

In May 2024, the U.S. Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). According to the FDA, the Final Guidance is designed to help medical device servicers understand when certain device... READ MORE

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) finalized “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. The Final Guidance reflects the FDA’s recommendations on informed consent and the regulatory requirements in place to... READ MORE