Six-Month Assessment: The Impact of Gottlieb’s Departure on FDA Priorities

How is the FDA charting its course after the surprise departure of Commissioner Scott Gottlieb in April 2019? What is Acting Commissioner Ned Sharpless doing to balance medical products oversight with patient access? Join Mintz Member Joanne Hawana and ML Strategies Senior Director Aaron Josephson, a former FDA senior policy advisor, for a conversation that will address these questions and cover key regulatory policy and legal topics implicating the agency, including:

• The reimagined regulatory paradigm for clinical lab tests (LDTs, IVDs, IVCTs)
• An update on the agency’s proposed approach to streamlining access to digital health technologies, including software
• The delicate balance between patient safety and patient access to regenerative medicine therapies
• Actions being taken under the Drug Competition and Biosimilars Action Plans 
• Topics for the next round of user fee negotiations