Food and Drug Law Institute

Food and Drug Law Institute As a neutral convener, FDLI provides a venue for stakeholders to inform innovative public policy, law, and regulation.

The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional networking opportunities in the field of food and drug law. FDLI’s scope covers all industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities in the U.S. and globally, including drugs, medical devices, food, dietary supplements, cosmetics, veterinary, and to***co products.

Excited to announce a new FDLI webinar happening on May 29!On April 1, FDA eliminated approximately 3,500 positions. Wha...
05/16/2025

Excited to announce a new FDLI webinar happening on May 29!

On April 1, FDA eliminated approximately 3,500 positions. What do these reductions and organizational changes mean for how industry engages with FDA on product reviews, postmarket compliance, guidances, and public health research? Panelists will offer insights into FDA’s evolving structure, implications of staff departures on product review and approval, potential disruptions to user fee negotiations, and practical tips for regulated industry on how to move forward during this period of transition.

Speakers:
E. Cartier Esham, CEO and Founder, Esham Strategies, LLC
Danielle C. Humphrey, VP Compliance Officer & Chief Regulatory Counsel, Becton Dickinson (BD)
Kurt R. Karst, Director, Hyman, Phelps & McNamara, P.C.
Moderated By Rachel Turow, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP

Register now at http://bit.ly/44AFfmw

The final countdown is on for the 2025 FDLI Annual Conference! We’re excited to welcome our food and drug law colleagues...
05/14/2025

The final countdown is on for the 2025 FDLI Annual Conference! We’re excited to welcome our food and drug law colleagues tomorrow at the Ronald Reagan Building in Washington, D.C.

FDLI staff is hard at work putting the final touches in place to ensure a smooth and engaging experience for all attendees.

If you haven’t already, be sure to review the agenda and plan your sessions.

It’s not too late to join us — in-person or virtually!

Register now at fdli.org/annual25.

We look forward to welcoming Robert F. Foster, Deputy General Counsel and Chief Counsel for Food, Research, and Drugs, H...
05/13/2025

We look forward to welcoming Robert F. Foster, Deputy General Counsel and Chief Counsel for Food, Research, and Drugs, HHS, for a fireside chat moderated by Perham Gorji on Day 1 of the FDLI Annual Conference.

Don't miss the chance to hear directly from an HHS leader at FDLI's premier food and drug law event of the year.

If you haven't registered yet, there's still time! Go to fdli.org/annual25 to learn more.

We’re excited to welcome U.S. Congressman Jake Auchincloss for a fireside chat on Day 2 of the 2025 FDLI Annual Conferen...
05/13/2025

We’re excited to welcome U.S. Congressman Jake Auchincloss for a fireside chat on Day 2 of the 2025 FDLI Annual Conference, moderated by Anna Abram, Senior Advisor, Akin.

You won't want to miss the chance to hear Congressman Auchincloss's insights on public health policy as it relates to food and drug law.

View the full agenda and register now at fdli.org/annual25

FDLI Annual Conference Speaker Spotlight: Kevin D. Hall, Former Senior Investigator, National Institutes of HealthHall w...
05/13/2025

FDLI Annual Conference Speaker Spotlight: Kevin D. Hall, Former Senior Investigator, National Institutes of Health

Hall will join the session, " America Healthy Again: The Impact of a New Strategy on FDA’s Nutrition Policies" where panelists will explore FDA’s initiatives to promote healthier food as part of the Make America Healthy Again initiative to reduce chronic disease.

View full details about this session and others at fdli.org/annual25

Don’t miss the opportunity to hear directly from FDA Commissioner Dr. Martin A. Makary in an engaging Fireside Chat at t...
05/12/2025

Don’t miss the opportunity to hear directly from FDA Commissioner Dr. Martin A. Makary in an engaging Fireside Chat at this week’s FDLI Annual Conference!

Makary will join FDLI President & CEO Christine M. Simmon for a discussion offering insights into the Trump Administration’s perspectives on the future of FDA regulation, agency priorities, and the broader public health policy landscape.

If you haven't already, there's still time to register at fdli.org/annual25

Time is running out to secure your spot at the FDLI Annual Conference — the must-attend event for the food and drug law ...
05/12/2025

Time is running out to secure your spot at the FDLI Annual Conference — the must-attend event for the food and drug law community.

Whether you work in government, industry, private practice, or academia, this is where experts and leaders come together to discuss the most pressing issues in FDA-regulated products.

📍 Washington, DC & Virtual
📅 May 15-16, 2025
🔗 fdli.org/annual25

Don’t miss this opportunity to stay ahead of regulatory trends, expand your network, and be part of the conversation shaping the future of food and drug law!

FDLI Annual Conference Speaker Spotlight: Abe Sutton, Director of the Center for Medicare and Medicaid Innovation and De...
05/08/2025

FDLI Annual Conference Speaker Spotlight: Abe Sutton, Director of the Center for Medicare and Medicaid Innovation and Deputy Administrator, Centers for Medicare and Medicaid Services (CMS)

Sutton will join the session, "The IRA, PBMs, and the Future of Drug Pricing: Legal, Legislative, and Regulatory Crossroads" where panelists will provide a comprehensive overview of the current and future regulatory landscape shaping drug pricing in America.

We look forward to hearing a CMS leader's perspective on the new Administration’s drug pricing priorities, potential legislative reform, litigation, and pricing for complex biologic medicines.

View the full agenda and register now at fdli.org/annual25

FDLI is accepting session proposals for the 2025 Enforcement, Litigation, and Compliance Conference—an essential confere...
05/07/2025

FDLI is accepting session proposals for the 2025 Enforcement, Litigation, and Compliance Conference—an essential conference for professionals in the drug, device, food, and to***co industries.

We're looking for timely, practical, and forward-thinking sessions that address the evolving regulatory and enforcement landscape. If you have insights to share on compliance strategies, litigation trends, or enforcement priorities, we want to hear from you!

Submit your proposal by May 23 at: https://bit.ly/4iT89lc

⏳ Last Chance to Save!Registration rates for the FDLI Annual Conference go up tomorrow! Join leading professionals and r...
05/07/2025

⏳ Last Chance to Save!

Registration rates for the FDLI Annual Conference go up tomorrow! Join leading professionals and regulators in food and drug law for essential insights and networking.

Secure your spot today: fdli.org/annual25

Just confirmed! We're excited to announce that Grace Graham, FDA's Deputy Commissioner for Policy and Legislation, and I...
05/05/2025

Just confirmed! We're excited to announce that Grace Graham, FDA's Deputy Commissioner for Policy and Legislation, and International Affairs, will deliver a keynote address on Day 2 of the 2025 FDLI Annual Conference!

As the FDA's point person for agency engagement with Congress, the Administration, global counterparts and partners, and state-level policymakers, Graham brings keen insights on the FDA's approach to the most critical public health issues.

View the full agenda and register now at fdli.org/annual25

The countdown is on—just a little over a week until the 2025 FDLI Annual Conference, happening May 15–16 in Washington, ...
05/05/2025

The countdown is on—just a little over a week until the 2025 FDLI Annual Conference, happening May 15–16 in Washington, DC and virtually!

🎤 We’re honored to welcome Dr. Marty Makary, Commissioner of Food and Drugs, FDA, as this year’s keynote speaker. Dr. Makary will offer the Trump administration’s perspectives on the future of food and drug regulation, legal priorities at FDA and HHS, and the broader public health policy environment. Their remarks will shed light on potential directions and considerations that may influence the administration’s regulatory and policy agenda.

💡 The FDLI Annual Conference is the leading event for food and drug law professionals. Join top voices from FDA, industry, law, and academia for two days of essential updates, networking, and forward-thinking discussion.

In these unprecedented times, FDLI remains your trusted guide, helping you make sense of complex regulatory landscapes and find the answers you need to move forward with confidence. View the full agenda and register now at fdli.org/annual25

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