Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more
In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more