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FDA 'May Hold Private Meetings' Offer Eases Sunscreen Monograph Tension

 
• By Malcolm Spicer

Proposed final sunscreen monograph published in February provided more clarity for TEA sponsors to engage with agency, but May publication of final guidance on MUsT for topically applied ingredients for OTC drug monograph could motivate TEA sponsors for sunscreen and other topical active ingredients to push their proposals forward.

Private or Public - Traffic sign with two options - services and companies owned by state or private businessman. Socialist / Capitalist question of privatization, school system, health service - Image

Long-stalled proposals for topical drug additions to the US Food and Drug Administration's OTC monograph could begin making progress as the agency offers private meetings with sponsors on details of their maximal usage trials (MUsT).

A proposed final sunscreen monograph published in February provided parameters for sponsors' work on time and extent applications, but the...

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More from Regulation

UK Org ‘Snapshot’ Sampling: Most Third-Party Beauty On Four Ecommerce Sites ‘Likely’ Counterfeit

 
• By Eileen Francis

UK consumer advocacy organization finds more than two-thirds of 34 skin care and makeup products it purchased from third party sellers on major ecommerce sites are likely fake.

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By David Ridley

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

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

 
• By Lauren Nardella

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

 
• By Eileen Francis

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.

More from Policy & Regulation

Producers Sue Oregon Over ‘Crushing’ EPR Recycling Law, Call It Unconstitutional

 
• By Eileen Francis

A national wholesalers’ trade group is suing Oregon, claiming its EPR law, which requires producers to register, report packaging data and pay fees, is unconstitutional and overly burdensome.

Senate HELP Committee Adds Sunscreen Regulation Overhaul To OMUFA Reauthorization

 
• By Lauren Nardella

OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.

Sunscreen Regulation Reforms Still Could Hitch Ride On Senate OMUFA Reauthorization Bill

As stakeholders and lawmakers pin their hopes on OMUFA reauthorization as a vehicle for enacting sunscreen regulatory changes, Senate version of the bill could be the ticket after a sunscreen-specific amendment withdrawn in the House.