Mintz’s FDA team will be participating in sessions at the Food and Drug Law Institute’s (FDLI) annual conference that addresses complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry on May 2-3, 2019.
The two-day event provides in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, the private bar, non-profits, patient and consumer advocates, consulting organizations, and academia.
Bethany Hills, Chair of Mintz’s FDA practice, will discuss how an influx of new regulatory classifications creates a “blank” page for 510(k) submissions claiming substantial equivalence, during the “Evolving 510(k) Program and De Novo Process” breakout session on Thursday.
The following day, Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, will participate on a panel titled, “Precision Medicine, Next-Generation Sequencing, and Diagnostics.” Mr. Josephson and his fellow panelists will explore how these fields have evolved drastically in recent years, leading FDA and others to call for regulatory clarification and reform.
Later, Counsel Joanne Hawana will address how tools provided to FDA under the 21st Century Cures Act have been used by CBER to promote the development of new gene, cell, and tissue therapies, in “Regenerative Medicine, Gene Therapies, and FDA Regulation.”
Mintz and ML Strategies’ interdisciplinary team of FDA attorneys and policy professionals partner with clients to interpret and influence the policymaking process while effectively bringing a product to market, maintaining compliant operations, and maximizing profitability.
For more information about Mintz, please visit www.mintz.com.