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A myriad of AI, science, and technology experts explore the real challenges and enormous opportunities facing entrepreneurs who are building the future of health. Raising Health, a podcast by a16z Bio + Health, dives deep into the heart of biotechnology and healthcare innovation. Join veteran company builders, operators, and investors Vineeta Agarwala, Julie Yoo, and Jorge Conde, along with distinguished guests like Mark Cuban, Greg Verdine, Fei-Fei Li, and Suchi Saria, as they explore the i ...
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Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serious incidents—such as hospitalizations, infections, disfigurement, or medically treated allergic reactions—within 15 business days. They must also maintain records of all adverse events for six years (or three years for small businesses).
Practically, this requires setting up a system to capture and assess customer complaints, determine seriousness, and document actions taken. Beyond compliance, this serves as a safety and trust mechanism—helping protect consumers, prevent regulatory actions like warning letters or recalls, and strengthen brand credibility.
For further guidance, contact the Kulkarni Law Firm.
www.kulkarnilawfirm.com
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