FDA Policies: Reflecting on the Past, Understanding the Present, and Preparing for the Future

FDA regulatory experts Rick Quinn and Jennifer Diaz presented a dynamic one-hour webinar titled “FDA Policies: Reflecting on the Past, Understanding the Present, and Preparing for the Future.” In this timely session, they reviewed historic FDA policy milestones that have shaped today’s regulatory framework amid the new administration's policy goals, including the Make America Healthy Again (MAHA) initiative--targeting nutrition, chemicals in food supplies, and foodborne illnesses--as well as efforts to reduce reliance on foreign drug development and promote domestic manufacturing. Gain an overview of current enforcement priorities, changes in approach to facility inspections, and other impacts of current priorities. Analyze hot-button issues affecting foods, the influence and use of Artificial Intelligence, and new FDA guidance's.

Ideal for lawyers, regulatory professionals, and business leaders in importing, manufacturing, or legal fields, this webinar equips you with practical tips to navigate compliance risks, leverage new priorities, proactively prepare for regulatory changes, avoid costly missteps, and position your organization for future success.

00:00 – Introduction of the Presenters, Jennifer Diaz and Rick Quinn | Diaz Trade Law
03:04 – Agenda
04:40 – Policy Context & Device Impact
10:18 – The Enforcement Evolution
16:05 – Import Refusals
17:27 – Observable Trends
20:42 – Current Enforcement Landscape
29:14 – Three Priority Areas: Quality Systems, Cybersecurity/Safety, Supply Chain
34:14 – Enforcement Patterns
44:02 – AI/ML Device Regulation
53:13 – Upcoming Guidance
59:15 – Resources and Support 

 

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