Hung Trinh, Senior VP of Operations at Seneca Therapeutics and CMC/MFG Consultant and Managing Director at Vertex Biopharm Consulting, shared a post on LinkedIn:
“FDA: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ‘New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.’
This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement.
The guidance discusses the statutory and regulatory criteria for eligibility for 3-year exclusivity and provides recommendations on the content and format of requests for 3-year exclusivity in the form of questions and answers (Q/As).
FDA intends to update this draft guidance document to include additional Q/As as appropriate.”
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