What is the Origin of Priority Review Pathway?

The pathway was formally established as part of the FDA's regulatory reform efforts, recognizing the public health need for faster access to truly transformative medical innovations. The term "Priority Review" contrasts with the standard review timeline, signifying a commitment of additional resources to shorten the regulatory assessment period. Its existence is a mechanism to incentivize pharmaceutical research in areas of high unmet medical need.

What is the Mechanism of Priority Review Pathway?

The priority review mechanism functions by setting a regulatory clock of six months for the FDA to act on an application, compared to the standard ten months. This acceleration is achieved by allocating senior review staff and prioritizing the application throughout the evaluation process, from preclinical data to clinical trial results. For complex hormonal products, this pathway ensures that groundbreaking therapeutic advances, such as a novel peptide or a highly specific receptor modulator, reach patients in a timely manner, upholding the goal of rapid clinical benefit.

Priority Review Pathway

Meaning

A specialized regulatory designation granted by the U.S. Food and Drug Administration (FDA) to expedite the review of a New Drug Application (NDA) or Biologics License Application (BLA). This pathway is reserved for drugs that, if approved, would represent a significant improvement in the safety or effectiveness of treating a serious condition compared to existing therapies. For hormonal health, this designation can accelerate the availability of novel endocrine treatments or delivery systems for life-threatening or debilitating conditions.