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Practice Tip: FDA Issues Draft Guidance for REMS
On Sept. 30, 2009, the Food and Drug Administration (FDA) issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics when the Agency believes additional precautions are necessary to ensure that the benefits of a drug or biologic outweigh its risks. The FDA is placing increased reliance on its REMS authority and, as a result, REMS assessments and implementation have placed increased demands on time, money, and resources for sponsors and for physicians and hospitals.
The draft document, Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modification (“REMS Guidance“), reveals the Agency's current thinking on the format and content that manufacturers should use in developing proposed REMS.
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When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.