FDA regulations

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

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.

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.

French Broad Chocolates PBC recalls Bette's Bake Sale Bonbons in 6pc, 12pc, and 24pc boxes (batch numbers 260414 and 260417) due to undeclared walnuts that pose allergy risks.

FDA adds constituents to the established list of harmful and potentially harmful substances in tobacco products and tobacco smoke under the Federal Food, Drug, and Cosmetic Act.

The FDA amends its Commissioner's National Priority Voucher Pilot Program public hearing notice to reflect changes in meeting dates, addresses, and contact information; original hearing was announced March 23, 2026.

The FDA issues a final 10-year debarment order against Kimberly Schaff Kiehl, prohibiting her from importing or offering for import any drug into the United States based on felony convictions related to drug importation.

FDA classifies mandibular-movement-based sleep apnea testing devices as Class II medical devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.

Remel Inc. issued a Class II recall for Yeastone Broth (2,819 units distributed worldwide) due to potential incorrect AST results during quality control that may delay antifungal treatment responses.

FDA classifies the setmelanotide eligibility gene variant detection system as class II medical device with special controls to ensure safety and effectiveness for clinical chemistry and toxicology applications.

Harvard Drug Group recalls Memantine Hydrochloride Extended-Release 7 mg capsules nationwide due to failed dissolution specifications that may cause temporary or reversible health problems.

FDA classifies digital therapy devices for amblyopia as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burdens for this ophthalmic category.