Which FDA expedited review program is intended for drugs that treat serious conditions and fill an unmet medical need?

The Fast Track program is designed specifically for drugs that address serious medical conditions and fulfill an unmet medical need. This program allows for more frequent communication between the FDA and the drug developers, aiming to expedite the development and approval process. By providing the option for rolling submission of the New Drug Application (NDA) or Biologics License Application (BLA), the Fast Track designation helps bring important therapeutic options to patients more quickly.

The program is particularly beneficial for conditions that have no current treatment options or where existing treatments are inadequate. Overall, the Fast Track designation is a crucial part of the FDA's strategy to enhance patient access to innovative therapies, especially those that can make a significant difference in managing serious health challenges.