What’s New Pussycat? FDA Assists Drug Sponsors Requesting New Clinical Investigation Exclusivity

Key Takeaways – FDA explains what must be “new” to qualify for three years of non-patent market exclusivity. In a new draft Q&A guidance, FDA walks sponsors through what makes a clinical investigation “new,” how to support exclusivity requests, and how the agency will evaluate them — aiming to balance innovation incentives with timely generic competition….
By: Arnall Golden Gregory LLP