U.S. Life Sciences Outlook 2023 (Part II): Anticipated Agency Policy Developments

Join Ropes & Gray’s life sciences and health care attorneys on a four-part podcast series exploring regulatory, compliance and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2023. This second episode will focus on anticipated policy developments from FDA and CMS in 2023. Topics discussed include rulemaking implications of the Food and Drug Omnibus Reform Act (FDORA), accelerated approval reform, potential digital health device and cybersecurity guidance, the end of the public health emergency, the Inflation Reduction Act, Part D reforms, and CMMI and HRSA action around the 340B program.