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FDA’s Accelerated Pathways Are the New Normal
The FDA’s Accelerated Approval, Breakthrough Therapy Designation, Fast Track, Orphan Drug status, and Qualified Infectious Disease Product pathways facilitate faster development and approval of NDAs addressing unmet needs. According to the FDA’s annual report, two-thirds of novel drugs approved in 2015 used at least one accelerated pathway, while a third used two or more. PAREXEL and the nonprofit Network for Excellence in Healthcare Innovation share results of a survey of twenty national, regional, public, and private payers, which explain how they view these pathways and products.
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.
