Recent FDA activities include education for consumers on hand sanitizers and biosimilars, and guidance for testing the irritation/sensitization potential of topicals in relation to abbreviated new drug applications. Following is a roundup.
This guidance provides recommendations for the design and conduct of studies to evaluate the in 17 vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery 18 system (collectively referred to as TDS2).