REMS: Is it the end of the world as we know it?
Risk Evaluation and Mitigation Strategies: For manufacturers, do REMS represent a tremendous potential for confusion or an opportunity for growth? Perhaps both. Manufacturers who implement effective programs can enhance patient access to medications, further ensure appropriate utilization and potentially improve patient outcomes. Manufacturers whose execution falls short stand to lose market share or even risk increased regulatory scrutiny.
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The Weight-Loss Gold Rush: Legal and Regulatory Implications
July 11th 2024Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.
Healthcare Marketing Strategies for Reaching Diverse Audiences
May 14th 2024Amanda Powers-Han, Chief Marketing Officer, Greater Than One, and Pharmaceutical Executive Editorial Advisory Board member, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but also contribute to improved patient care outcomes, challenges faced in crafting culturally sensitive messages, and much more.