Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance

23 May 2018

Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.

FDA draft guidance that underscores its reliance on maximal usage trials for including sunscreen and other topical drugs in OTC monographs could have more firms contemplating making products available through new drug applications instead of the monograph program's generally recognized as safe and effective reviews.

The draft guidance published May 22 – “Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in...