The FDA's regulatory landscape is evolving rapidly, with changes that affect drug and device approvals, post-market surveillance, and interactions with industry stakeholders. Recent trends include the cancellation of advisory committee meetings, increased scrutiny of accelerated approvals, leadership turnover, and regulatory shifts in AI, oncology, and digital health.

This session will provide a comprehensive overview of current FDA processes, recent policy changes, and their impact on regulatory compliance. Attendees will gain valuable insights into how these shifts may affect their development programs, regulatory submissions, and post-market strategies.

Learning Objectives:-

• Understand FDA's Current Approval Processes: NDAs, BLAs, 510(k), PMAs, De Novo, Breakthrough Designations.
• Analyze Recent FDA Changes, including AdComm cancellations, staffing shifts, and revised accelerated approval policies.
• Evaluate Post-Marketing Surveillance Trends: Learn how stricter post-market data requirements impact drug/device approvals.
• Identify Key Regulatory Challenges: AI/ML in healthcare, oncology drug approvals, and the impact of FDA leadership turnover.
• Prepare for FDA Interactions & Submissions: Strategies for navigating regulatory reviews and engaging with the agency effectively.

Areas Covered in the Session:-

• Overview of FDA Drug & Device Approval Pathways (NDAs, BLAs, PMAs, 510(k), De Novo, etc.)
• Recent FDA Changes & Their Impact (AdComm cancellations, leadership shifts, staffing turnover)
• Accelerated Approvals & Post-Marketing Surveillance Trends
• Regulatory Shifts in Oncology, AI/ML, & Digital Health
• FDA’s Expedited Programs (Breakthrough, Fast Track, Priority Review, etc.)
• New FDA Policies on Advisory Committees & Review Processes
• Leadership Changes & Their Effects on the FDA’s Decision-Making
• Industry Best Practices for Navigating the Changing FDA Landscape.

Background:-

The U.S. Food and Drug Administration (FDA) plays a pivotal role in regulating drugs, biologics, and medical devices, ensuring their safety, efficacy, and quality. However, the agency is currently undergoing significant changes, including reduced advisory committee (AdComm) meetings, leadership turnover, evolving accelerated approval policies, and increased scrutiny on post-market surveillance. These shifts are reshaping regulatory strategies for pharmaceutical, biotech, and medical device companies.

Understanding these changes is crucial for regulatory professionals, manufacturers, investors, and healthcare stakeholders to navigate the evolving FDA framework effectively.

Why Should You Attend?

• Stay updated on FDA's Evolving Policies: Gain insights into recent regulatory changes that may impact drug and device approvals.
• Learn About the Decline in AdComms: Understand why the FDA is skipping advisory committees and how this affects regulatory decisions.
• Assess Leadership & Policy Shifts: Explore the impact of key resignations and staffing changes on FDA review processes.
• Understand New Trends in AI, Digital Health, and Oncology Regulation: Get ahead of upcoming regulatory challenges in digital health, AI-driven diagnostics, and oncology drug approvals.
• Prepare for Future FDA Interactions: Develop strategies for compliance, submissions, and engagement with the FDA under the new regulatory landscape.

Who Will Benefit?

• Regulatory Affairs Professionals (Pharma, Biotech, Medical Devices)
• Clinical & Medical Affairs Executives
• Quality Assurance & Compliance Officers
• Pharmaceutical/Biotech CEOs & COOs
• R&D Scientists & Drug Development Teams
• Legal & Compliance Professionals in Healthcare
• Business Development & Investors in Life Sciences.