Why Attend

 

Agenda
Location & CLE

Explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for drugs
  • New Drug Application Process (NDA)
  • Biologics and biosimilars
  • Post-approval drug safety issues
  • Advertising and promotion requirements
  • FDA’s enforcement tools and procedures

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Kefauver-Harris Amendments
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman)
  • Biologics Control Act
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Food and Drug Administration Modernization Act (FDAMA)
  • Food and Drug Administration Act (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Prescription Drug User Fee Act (PDUFA)
  • Generic User Fee Amendments (GDUFA)
  • Drug Quality and Security Act (DQSA)
  • 21st Century Cures Act

 

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

 

Register!

Industry & Firms

$1399
  • +$400 for non-members

Non-Profit

$899
  • +$200 for non-members

Government

$899
  • +$200 for non-members

Academic

$899
  • +$200 for non-members

Student

$899

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To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

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