Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
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maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs.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.
You may also be interested in...
CHPA Consulting With OTC Antiseptic Advocates As Sunscreen GRASE Push Begins
Following FDA’s proposed sunscreen rule in February, the Consumer Healthcare Products Association has opened a line of communication with the American Cleaning Institute to gain insight into the GRASE data delivery process that kicked off for consumer antiseptic products in September 2016.
FDA Clears Outdated Sunscreen Petitions From Queue With Trio Of Denials
The agency refers L’Oreal, Shiseido’s Bare Escentuals and Rapid Precision Testing Laboratories to its newly proposed sunscreen rule, which covers most of the points raised in their petitions. Seeking GRASE status for powder dosage forms and higher concentrations of avobenzone, among other asks, the rejected citizen petitions trace back as far as a decade.
OTC Monograph Legislation Clears Another Hurdle Despite Exclusivity Concerns
Democrats' opposition to the length of the exclusivity allowed for some new monograph products didn't stop them from voting to send US OTC monograph overhaul legislation on for a vote by the full House. House/Senate differences and some members' questions on whether new exclusivity is needed could make it harder for reforms to pass this year.