Articles related to REGULATORY AFFAIRS

Accreditors described new programs for artificial intelligence and immunoglobulin services, revised oncology dispensing materials, and more frequent DMEPOS surveys, with differing eligibility, payer recognition, and compliance implications across specialty pharmacy settings.

As sedation and anesthesia for extensive tattooing draw greater attention, questions about credentialing, facility standards, prolonged procedures, local anesthetic toxicity, and regulatory oversight remain unsettled across practice settings.

The FDA has approved tavapadon, a selective D1/D5 dopamine receptor partial agonist, for adults with Parkinson disease following phase 3 studies demonstrating benefit both as monotherapy in early disease and as adjunctive therapy to levodopa.

Attorneys speaking at a specialty pharmacy meeting warned that increased federal attention to fraud, waste, abuse, controlled substances, and reimbursement practices is driving greater scrutiny of pharmacies. The discussion focused on compliance preparedness rather than new regulatory requirements.

The FDA classified a recall of thyroid tablets USP 30 mg as Class I after identification of a superpotent product lot. The recall affects 1,955 bottles and carries risk of serious adverse health consequences, making prompt inventory review and product removal necessary.

The FDA approved updated 2026-2027 formulations of Pfizer-BioNTech, Moderna, and Novavax COVID-19 vaccines targeting the XFG variant, aligning with advisory committee recommendations for the upcoming vaccination season.