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.
FDA Updates Instructions For Reporting Serious Adverse Events Under MoCRA
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.
More from Regulation
• By
Single-use packaging producers subject to Oregon state’s Extended Producer Responsibility law that didn’t meet the 31 March deadline to report their packaging materials are given a grace period to report until 30 April, says Circular Action Alliance, the organization carrying out the EPR program.
• By
Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
• By
Personal care companies selling in California that suspect they are subject to its listing of a common stabilizer and packaging material should collect Certificates of Analysis for all raw materials, pursue third-party formula testing and retain counsel.
• By
Single-use packaging producers subject to California’s SB 54 recycling law, which implements a statewide EPR plan, should continue to prepare for its implementation, even as they enter a ‘prolonged period of uncertainty,’ says consultant Michael Washburn.