Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines," dated May 2007. The guidance document is intended to provide to sponsors of seasonal inactivated influenza vaccines guidance on clinical development approaches to support a biologics license application (BLA). The guidance provides recommendations concerning clinical data to support traditional and accelerated license approvals for new seasonal inactivated influenza vaccines. The guidance announced in this notice finalizes the draft "Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccine" dated March 2006.