Articles related to REGULATORY AFFAIRS

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.

“There are a lot of people with autism who don’t have a folate deficiency, and there are a lot of people with a folate deficiency who don’t have autism.” — Ben Rein, PhD

The Aptima HPV assay uses messenger RNA detection to identify infections most likely to lead to cervical cancer.