HP&M to Host Webinar on the FDA Appeals Process

January 19, 2012

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.  On March 21, 2012 (12:30 – 2:00 PM ET), Hyman, Phelps & McNamara, P.C. will host a free webinar, titled “FDA Appeals – Improving Your Odds of Success; Trends, Expectations, Strategies.”  You can register for HP&M’s March 21st FDA Appeals Process webinar here.

The 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 HP&M attorneys Josephine Torrente and Jeffrey Shapiro, who have years of experience helping drug and device companies to navigate the appeals processes.  (Mr. Shapiro recently posted on FDA’s draft guidance on medical device appeals. During the webinar, Ms. Torrente and Mr. Shapiro 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 within the agency; and 
  • Answer participants’ questions submitted during or before the webinar.

The FDA appeals process is a hot topic these days.  We anticipate a robust turnout for the webinar, so register early