Hyman, Phelps & McNamara P.C. presents a webinar on FDA Appeals – Improving Your Odds of Success


March 21, 2012

12:30 to 2:00 p.m. ET

Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used effectively, can maximize success.

This webinar will provide a brief overview of the appeal processes in the drug and device centers, followed by a focused, in-depth discussion of various case studies and trends. Participants will gain an understanding of how to use appeal timing, content, meeting strategy, and potential outcomes to their full advantage.

The webinar will feature Hyman, Phelps & McNamara P.C. attorneys, Josephine Torrente and Jeffrey Shapiro, who have years of experience helping drug and device companies to navigate the appeals processes. They will:

  • Describe the appeals processes within CDRH and CDER, including appropriate appeal content and timeframes for agency response;
  • Share their insights on potential outcomes of an appeal, including risks and benefits;
  • Analyze publicly disclosed case studies and evaluate appeal trends;
  • Provide strategies for success and recommendations on how to effectively appeal the agency;
  • Answer participants’ questions submitted during or before the webinar.