Recent Food and Drug Administration regulations affecting small businesses

FDA seeks 60-day public comment on proposed information collection requirements for Radioactive Drug Research Committees governing radioactive drug use in basic research under the Paperwork Reduction Act.

FDA is accepting public comments for 60 days on a proposed information collection for qualitative social and behavioral research data submissions related to food, dietary supplements, cosmetics, and animal feed.

FDA holds a virtual public meeting to solicit comments on the Animal Drug User Fee Act program and considerations for its next reauthorization.

The FDA will hold a public meeting to solicit comments on the Animal Generic Drug User Fee Act program and recommendations for its next reauthorization.

FDA publishes draft guidance (VICH GL8(R1)) for stability testing of medicated premixes intended for animal feed incorporation, developed through international harmonization standards.

FDA approves MNEXSPIKE (COVID-19 Vaccine, mRNA) as a rare pediatric disease product eligible for priority review voucher redemption as of May 30, 2025.

FDA approves MRESVIA respiratory syncytial virus vaccine under a rare pediatric disease priority review voucher program on June 12, 2025.

FDA approves MRESVIA (Respiratory Syncytial Virus Vaccine) on May 31, 2024, redeeming a material threat medical countermeasure priority review voucher under the FD&C Act.

FDA determines CHEWTADZY (tadalafil) chewable tablets were not withdrawn for safety or effectiveness reasons, enabling generic ANDA approvals for 5mg, 10mg, and 20mg formulations.

FDA classifies manual surgical instruments for orthopedic implant patient selection as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden on manufacturers.

FDA classifies transcutaneous electrical nerve stimulators for congestion relief as class II devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.

FDA's Pharmacy Compounding Advisory Committee will hold a public meeting to advise on bulk drug substances for inclusion in the Section 503A list, with a public docket open for comments.

FDA reclassifies non-invasive bone growth stimulators (product codes LOF and LPQ) from class III to class II devices, requiring premarket notification and establishing special controls for safety and effectiveness.

FDA approved AREXVY respiratory syncytial virus vaccine under the rare pediatric disease priority review voucher program on June 7, 2024, enabling the sponsor to redeem a voucher for expedited review of a future application.

FDA amends animal drug regulations to reflect application actions for new animal drugs during October through December 2025 and improve regulatory accuracy and readability.