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Registrar Unveils Software To Assist MoCRA Stakeholders In Filing Adverse Event Reports

 
• By Eileen Francis

Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products globally, transmits information to internal stakeholders and formats serious events to the FDA Medwatch format for submission.

Adverse Event

Regulatory consultancy firm Registrar Corp. has launched Adverse Event Management (AEM) Software to assist cosmetic companies as they seek to comply with serious adverse event reporting requirements under the Modernization of Cosmetics Regulation Act.

Noting in a 23 July release that many cosmetic companies are ill-prepared for FDA’s new adverse event requirements, the Hampton,...

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More from Regulation

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.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

Animal Studies Would Not Provide ‘Meaningful Insights’ Into UV Filter Safety - Study

 
• By Lauren Nardella

A new study on the safety of sunscreen filters relies on an alternative assessment methodology and concludes that six sunscreen UV filters are unlikely to be carcinogenic.

EU’s Small, Medium Beauty Industry Pushing For Clarity In Revised CPR

French SME association COSMED will push the European Commission for a “clear checklist” and criteria on how substances in the Cosmetic Products Regulation are assessed by Member States, as well as more clarity on the exemption process and timelines.

More from Policy & Regulation

Beauty Industry: Counter Impact Of State Legislation By Connecting With Lawmakers – IBA

 
• By Eileen Francis

Beauty stakeholders will undoubtedly feel the impact of new state laws targeting cosmetic ingredients and packaging and should therefore open lines of communication with state lawmakers.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.