Potential Changes to the Generally Recognized as Safe (GRAS) Program
Background: The GRAS Framework The Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) was established by Congress in 1958. In the Code of Federal Regulations, the rules that the FDA applies to food additives are spelled out in sections 21 CFR 170.3 and 170.30. A food additive is considered to […]
ASTM Workshop on the Characterization of Hydrogel Medical Devices: Key Takeaways
On May 6, 2025, the ASTM Workshop on the Characterization of Hydrogel Medical Devices brought together researchers and engineers to discuss current test methods for hydrogels in medical devices. Led by Stephen Spiegelberg of Cambridge Polymer Group, the workshop focused on current test methods, industry challenges, and the need for new standards. Why Are ASTM […]