Articles related to REGULATORY AFFAIRS

A Senate investigative report alleged that federal health officials received early signals of myocarditis and pericarditis following mRNA COVID-19 vaccination in adolescents and young adults months before public advisories were issued, citing internal agency communications and subpoenaed HHS documents.

The FDA announced on April 30, 2026 it is considering removing GLP-1 receptor agonists from the 503B bulks list, with public comment open through the end of June 2026.

FDA priority review vouchers granted to three psychedelic developers and a recent executive order may accelerate regulatory timelines for psilocybin and related compounds, with clinical availability potentially within 12 months pending positive Phase 3 data.

CMS finalized a four-code complexity-based structure replacing legacy radiation oncology G-codes effective January 1, 2026, consolidating image guidance and treatment delivery under codes 77387, 77402, 77407, and 77412.

The AMA’s CPT Editorial Panel approved a structural overhaul of maternity care coding, replacing global obstetric codes with phase-specific reporting across antepartum, labor management, delivery, and postpartum care effective January 1, 2027.

CPT code 0936T became active in January 2025 for retinal photobiomodulation, with reimbursement determined claim-by-claim and scope-of-practice limits restricting who may perform the procedure.