FDA Appeals – Improving Your Odds of Success: Trends, Expectations, Strategies

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 presentation provides 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.

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