HHS regulations

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

FDA determines REVIA (naltrexone hydrochloride) 50mg tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory standards.

SAMHSA proposes new information collection requirements for substance abuse and mental health services programs; public comment period details available in Federal Register notice.

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