This week, the FDA published a final rule on medical gases. Final guidance was issued on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. Final guidance was also issued on drug development for diabetic foot infections, bioanalytical method validation and study samples, clinical pharmacology, and date decisions under GDUFA. Draft guidance was published on demonstrating interchangeability. The agency is also seeking nonvoting industry members for its advisory committees.
Source: Drug Industry Daily