Orange Book Blog

American Conference Institute’s very popular “FDA Boot Camp” returns to San Francisco later this month, May 29-30.

The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies.  The conference features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

Presentations on the agenda include:

• The Basics: Understanding and Working with the FDA — Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Patent and IP Overview: Hatch-Waxman, Trademark Protection, and More
• From Theory to Practice: FDAAA, Future FDA and Legislative Priorities, Other Enforcement Initiatives, and Beyond
• Non-Patent Exclusivity
• Bioequivalence: What Lawyers Need to Know
• Follow-On (Comparable or Biosimilar) Biologics

For more information or to register, please visit the conference website.