For the Drug, Device, Food, and Tobacco Industries
Morrison & Foerster is proud to sponsor FDLI's annual Enforcement, Litigation, and Compliance Conference which brings together industry, regulators, attorneys, litigators, academics, and consultants to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, and recent cases and settlements. This year’s conference will be a virtual event, offering an opportunity to hear from and interact with top officials from FDA, DOJ, FTC, and other government agencies. As we move out of the COVID-19 pandemic, come hear from your peers about how they are staying compliance and inspection ready as FDA ramps back up inspections, what companies need to do to plan for and manage enforcement risk, trends in criminal and civil litigation, and government priorities for the new year.
On December 9, 2021, Morrison & Foerster partner Stacy Amin will moderate a fireside chat from 11:15 AM–12:00 PM ET featuring Arun G. Rao, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, US Department of Justice and Julia G. Tierney, Acting Chief of Staff, Office of the Commissioner, FDA.
On December 10, 2021, Morrison & Foerster of counsel Brigid Bondoc will participate in the panel discussion, Diagnostics: FDA Policies, Enforcement Priorities, and Pending Legislation from 12:00–12:45 PM ET alongside Carly McWilliams, Head of Regulatory Policy for Roche Diagnostics, and moderated by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC. This panel will address FDA’s policies for diagnostic tests (LDTs, DTC, at-home, pharmacogenetic, wellness tests, COVID tests, etc.) and the shifting sands over the last several years. Speakers will examine FDA warning letters and other compliance and enforcement activities that have had an impact on the industry. The panel will also examine what would change under the VALID Act as well as what the compliance and enforcement landscape might look like in the future.