FDA Regulatory Fundamentals 101 With Ethics Session

March 9, 2015 1:00pm

Seth A. Mailhot
Michael Best & Friedrich LLP (Washington, DC)

1:00 Fundamentals of FDA Regulatory Law

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 preapproval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp.
Topics to include:

  • FDA Mission
  • FDA Organization
  • History of FDA Laws
  • Acronyms and Terminology
  • Clinical Trials Process
  • Types of New Drug Applications
  • The Review Process
  • The Hatch Waxman Act
  • Legal Barriers to Approval
  • Biological Products
  • The Basics of Device classification and approval
  • Post-marketing issues and enforcement, including recalls

4:00 Resolving Ethical Challenges Encountered During the Drug Approval Process

This one hour program will explore ethical issues that may arise in the context of communications with FDA on behalf of clients. The program is based on scenarios involving situations in which FDA requires full disclosure of adverse information and authority. For example:

  1. In the context of citizen petitions FDA requires certification that the petition includes all information and views on which
    the petition relies as well as data and information known to the petitioner which is unfavorable to the petitioner. 21 CFR 10.30. The discussion will cover the implications of that certification upon an attorney in light of Rules 1.6, 1.7 and 1.8 of the Rules of Professional Responsibility.

  2. In the context of an Advisory Committee meeting at which counsel is present, Committee members ask whether all data
    regarding adverse events have been reported to FDA. The discussion will cover the implications of the lawyer’s participation in light of the requirements of Rules 1.3, 3.4, and 4.1.

  3. Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending NDA. The discussion will cover the implications of Rule 1.11.