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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 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.

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

 
• By Eileen Francis

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%.

MoCRA Implementation Delay Creates More Legal Exposure For Stakeholders – Attorney

 
• By Eileen Francis

The delay in implementation of MoCRA is seen by many companies as a temporary reprieve, but it does create more legal uncertainty, says attorney Marissa Alkhazov of law firm Buchalter.

More from Policy & Regulation

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.

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

 
• By Michael McCaughan

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.

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

 
• By Eileen Francis

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%.