HHS regulations

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 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 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.

Center for Scientific Review will hold closed meetings to review and discuss National Institutes of Health grant applications and proposals.

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

FDA determines CHEWTADZY (tadalafil) chewable tablets were not withdrawn for safety or effectiveness reasons, enabling generic ANDA approvals for 5mg, 10mg, and 20mg formulations.

HRSA solicits public comment on a proposed Information Collection Request for performance measures related to the Transforming Pediatrics for Early Childhood Program under the Paperwork Reduction Act of 1995.

FDA determines REVIA (naltrexone hydrochloride) 50mg tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory standards.

This correction addresses a typographical error in the April 14, 2026 Federal Register notice regarding Medicare hospital inpatient and long-term care payment systems and quality program requirements for fiscal year 2027.

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.

The FDA seeks public comment on information collection requirements for orphan drugs; the 60-day comment period begins with this Federal Register notice.