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FDA on Hand Sanitizers, Topical Irritation Testing and Biosimilars - Vimarsana News

FDA on Hand Sanitizers, Topical Irritation Testing and Biosimilars

Published: April 21, 2023

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.

Source: cosmeticsandtoiletries.com
Related Topics:
Drug AdministrationUs Federal Trade CommissionFive European NationsDrug FactSensitization PotentialTopical Delivery SystemsTrade Commission
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs - Vimarsana News

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

Published: April 12, 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).

Source: fda.gov
Related Topics:
Drug AdministrationGuidance Issuing OfficeSubmit CommentsDrug EvaluationSensitization PotentialTopical Delivery Systems