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Evaluation ViewAttendees 39

Biopharmaceuticals (includes Biologics and Drugs)

FDA Forecast 2024: What Pharmaceutical and Biotech Regulatory Professionals can Expect from FDA Next Year

Wednesday, October 4, 2023
2:00 PM – 3:00 PM EDT
Location/Room: 511D
With the start of the new fiscal year, regulatory professionals working in the pharmaceutical and biotech industries are wondering what the regulatory year ahead looks like for the FDA – and the life sciences industry. In this 60-minute, fast-paced and lively session, leading regulatory intelligence professionals will present evidence-based predictions on what FDA will do in the coming fiscal year, with a focus on pharmaceuticals, biologics and cell and gene therapy products.

Presenters will offer a data- and facts-driven presentation looking at:

Things we know: The guidance, regulations, pilot programs and reports that FDA is required to publish under legislation and the user fee reauthorization, and what industry should look out for;

Ongoing challenges: Things we know the FDA will struggle with (or continue to struggle with) and what those challenges mean for industry; and

Potential wildcards: Low-probability, high-impact events that could cause major problems for the FDA and industry.

Learning Objectives:

  • Session attendees will take away from this session an advanced understanding of the trends, milestones, decision points and challenges that are most likely to affect their companies in 2024 and beyond.
  • Attendees will be better prepared to plan their regulatory strategies and ensure their companies are prepared for catalyst events and opportunities.