FDAnews
www.fdanews.com/articles/74237-id-biomedical-s-flu-vaccine-granted-fast-track-status

ID BIOMEDICAL'S FLU VACCINE GRANTED FAST-TRACK STATUS

July 12, 2005

ID Biomedical announced it has been advised by the FDA's Center for Biologics Evaluation and Research that the company's influenza virus vaccine (Fluviral) has been granted a fast-track designation.

Under the Food and Drug Administration Modernization Act of 1997, the Fast Track program was implemented to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening disease, and that demonstrate the potential to address unmet medical needs. The fast-track designation allows for frequent communications with the FDA and the possibility of submitting portions of marketing application, biologic license application (BLA), before the complete BLA is submitted.