| Hyman, Phelps & McNamara P.C. presents a webinar on |
| |
| FDA Appeals - Improving Your Odds of Success |
Trends, Expectations, Strategies
March 21, 2012 12:30 - 2:00 p.m. ET |
| |
| |
| Register |
| |
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.
|
Josephine Torrente's practice involves many aspects of pharmaceutical regulatory law, with a particular focus on new drug and biologic approval issues. In the pharmaceutical and biologics areas, Josephine has broad expertise in IND and NDA matters including clinical trial issues, 505(b)(2) NDAs, REMS, user fee issues, advisory committee meetings, orphan drugs, fast track, special protocol assessments, targeted therapy, cell and tissue based therapies, and oncology products. She has spoken publicly on fast track approaches to new drug development and approval, the potential for generic biologics, and issues related to drug marketing. See full bio.
Jeffrey Shapiro has represented medical device companies on FDA-related matters since 1994. He works extensively with large, small, and startup manufacturers on a broad spectrum of U.S. Food and Drug Administration (FDA) matters. He assists companies in developing regulatory strategies and preparing product applications, including IDEs, 510(k)s, and PMAs; with compliance matters, including MDRs, recalls, and GMPs; with advertising and promotion compliance; with regulatory due diligence; and with combination product issues. He also has expertise in FDA's regulation of human tissue based products. Mr. Shapiro has written and lectured extensively on a variety of FDA-related topics. Read his full bio and recent blog re: FDA's draft guidance on medical device appeals.
|
| |
| |
| Register |
|
|
