Current Class Of Risk Evaluation & Mitigation Strategies
This article was originally published in Pharmaceutical Approvals Monthly
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REMS 2.0: FDA Refining New Drug Safety Tools
FDA’s new post-marketing risk management authorities are receiving much more public attention in the context of the Avandia decision – but use of Risk Evaluation and Mitigation Strategies is actually declining. As FDAAA turns three, it is clear that REMS are going through some growing pains. The new tools will be refined, but they are definitely here to stay.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.