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FDA Updates Instructions For Reporting Serious Adverse Events Under MoCRA

 
• By Eileen Francis

The US Food and Drug Administration simplifies instructions for filing reports on serious adverse events under the Modernization of Cosmetics Regulation Act; promotes soon-to-launch electronic-reporting platform.

Adverse Event Reporting

Just weeks from the deadline for reporting serious adverse events (SAEs) under the Modernization of Cosmetics Regulation Act, the US Food and Drug Administration has updated instructions for filing reports to make the process easier, while promoting a soon-to-launch electronic submission platform.

Though the 14 December notice does not specify how the instructions for using the MedWatch Form 3500A are...

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More from Regulation

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations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

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

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.

More from Policy & Regulation

Unanimous Support Across House Energy And Commerce To Reauthorize FDA’s OMUFA Program

 
• By Malcolm Spicer

Committee voted 51-0 to approve five-year authorization of FDA program user fee program needed to support regulatory pathway for large majority of nonprescription drugs available in the US with amendment to expand stakeholder engagement with FDA.

US Tariff Exemption For Indonesian Materials Not Produced Domestically A Boon For Fragrance – FCA

 
• By Eileen Francis

The Fragrance Creators Association President & CEO Farah Ahmed commends the Trump Administration for exempting from tariffs Indonesian goods not naturally available or produced in the US, which recognizes the “essential” role of fragrance and essential oils.

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.