FDA rolls out new inspection coordination plan, lifts estradiol patch warning and HHS permits compounding of six peptides

FDA's drug center and inspections office have agreed on a new concept of operations (ConOps) to better coordinate inspections and compliance activities.

A U.S. senator introduced draft legislation that would expand FDA's authority to oversee artificial intelligence (AI) used in medical products.

The agency also removed a boxed warning from estradiol patch labels, reflecting updated safety data.

Meanwhile, the Department of Health and Human Services announced an interim policy allowing state-licensed pharmacies, federal facilities, and licensed physicians to compound six unapproved peptide bulk drug substances without enforcement action, provided they follow specified conditions.