FDA’s MUsT Draft Guidance Extends Challenge To Wider OTC Drug Industry

It’s known that challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors of late, but new draft guidance from the agency signals that MUsTs will be expected generally from companies looking to add topical ingredients to OTC drug monographs.

female scientist working with microscope

Newly released draft guidance from FDA underscores the agency’s increasing reliance on maximal usage trials (MUsTs) to support topical ingredients’ inclusion in OTC drug monographs.

The document could have more companies contemplating new drug approval pathways as an alternative to generally recognized as safe and...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

US FDA: No Replacement Yet For Animal Methods In Testing Systemic Effects Of Sunscreens

 
• By 

While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.

EU Proposal To Simplify Hazardous Chemical Rules For Cosmetics ‘Step In Right Direction’ - Industry

 

The European Commission’s Simplification Omnibus published July 8 is ‘step in right direction’ for streamlining processes and providing more legal certainty and predictability for regulations addressing cosmetics, says Cosmetics Europe.

Cloudy Tariff Conditions Expected To Linger In US

 

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.

More from Policy & Regulation

FDA Urged To Issue Formaldehyde Rule As California Finds Non-Compliance With State Ban

 
• By 

Stakeholders are still waiting for the US FDA to issue its widely anticipated proposed rule to prohibit formaldehyde and formaldehyde releasers from hair smoothing or straightening products.

Cloudy Tariff Conditions Expected To Linger In US

 

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.