
(AGENPARL) – SILVER SPRING mer 12 aprile 2023 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).
Fonte/Source: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-irritation-and-sensitization-potential-transdermal-and-topical-delivery-systems-andas