A 505(b)(2) application is a new drug application that contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This approach can lead to approval in a fraction of the time and cost required by traditional paths. For 505(b)(2) in particular, early assessment and preparation are key to identifying needs and avoiding redundancies to set the path to a profitable product. Pre-investigational new drug (PIND) meetings serve as a prudent step in this process and can guide development strategies that reduce time to market and can all but eliminate the possibility of clinical holds.
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.