Recent Food and Drug Administration regulations affecting small businesses

FDA classifies brain temperature measurement systems as Class II medical devices with special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

The FDA classifies radiation therapy marking devices as class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

The FDA determined that FENOGLIDE (fenofibrate) tablets at 40 mg and 120 mg strengths were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions.

FDA seeks 60 days of public comment on information collection requirements for Good Laboratory Practice standards in nonclinical laboratory studies.

FDA determines that OZEMPIC semaglutide 2mg/1.5mL solution was not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions.

FDA seeks OMB approval for juice processors and importers to implement hazard analysis and critical control point procedures under the Paperwork Reduction Act of 1995.

Pork King Good voluntarily recalls Sour Cream & Onion pork rinds and seasoning due to potential Salmonella contamination from milk powder ingredient.

FDA seeks input on a pilot program to evaluate AI-enabled technologies for improving efficiency and decision-making in early-phase clinical trials while maintaining regulatory standards.

Ghirardelli Chocolate Company recalls powdered beverage mixes due to potential Salmonella contamination linked to a California Dairies milk powder ingredient.

FDA announces a public advisory committee meeting on the 2026-2027 COVID-19 vaccine composition formula with an open docket for small business and public comment.

FDA renews the Anesthetic and Analgesic Drug Products Advisory Committee for two additional years, extending the charter through May 1, 2028.

We R Nuts recalls 254 Uncle Giuseppe's branded 11oz milk chocolate bridge mix containers due to undeclared milk, soy, and cashews that pose serious health risks to allergic consumers.

FDA releases its annual report on drug and biologics firms' performance in meeting postmarketing requirements and commitments mandated under the Federal Food, Drug, and Cosmetic Act.

FDA withdraws approval of three abbreviated new drug applications from Egis Pharmaceuticals Limited and others due to repeated failure to file required annual reports.

Ferris Coffee & Nut Co. recalls Frederik's By Meijer Vanilla Bourbon Trail Mix 9 oz. due to undeclared wheat and soy allergens posing serious health risks to sensitive consumers.