FDA Fundamentals and What to Expect During a Sponsor Meeting with the FDA

Sep 13, 2017 1:00pm – 4:15pm

Deborah M. Shelton
Partner, Leader of the Food & Drug Law Practice
McCarter & English, LLP

Naomi J.L. Halpern
Arent Fox LLP

12:30 Registration to Workshop A Aimed at providing a primer to professionals who have limited or no experience working with FDA on regulatory matters, this workshop will provide you with a basic overview of FDA regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of the FDA and walk you through the pre-approval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp.   Topics to be discussed include:  
  • FDA Mission
  • FDA Organization
  • Brief Historical Overview
  • Acronyms and Terminology
  • The Drug Approval Process
    • Overview of the research, development, and approval process for new drugs
  • Clinical Trials Process
    • The investigational new drug application (IND) – timing, content, and purpose
    • Outlining the phases of clinical trials (I-IV)
  • Types of New Drug Applications
    • ǔǔ The new drug application (NDA)—timing, content, purpose, and review process
  • Legal Barriers to Approval
  • The Hatch Waxman Act
    • Overview
    • The role of the Orange Book in the drug approval process: what is it, why is it Orange, and why is it important?
    • Regulatory Exclusivity (FDA)
      • Categories of regulatory (data) exclusivity— NCE (new chemical entity); NCI (new clinical investigation); ODE (orphan drug exclusivity); PED (pediatric exclusivity); New antibiotic exclusivity
      • Orange-Book Listed Patents
  • Biological Products
    • What are biological products? How do they differ from “drugs” and what is the same?
    • Brief Overview of the Biologics Price Competition and Innovation Act (BPCIA)
    • The role of the Purple Book: What is it, why is it Purple, and why is it important? How does it differ from the Orange Book?
  • Post-marketing issues and enforcement, including recalls
  • Advertising and Promotion Overview
    • Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
    • Office of Prescription Drug Promotion (OPDP)— duties, responsibilities, and enforcement authority
    • Identifying the role of the FTC in the advertising and promotion of drugs