Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines. It is intended to provide sponsors guidance on the clinical data needed to support a BLA and includes clinical development approaches to facilitate and expedite the licensure of new trivalent inactivated influenza vaccines. It also addresses both traditional and accelerated approval. To download this guidance, click here. To view this notice, click here.