Generic drug markets represent a unique niche where the strengths of a targeted PRV program could spur much-needed competition to lower prices, increase supply, and prevent access-threatening ...

This program aims to provide a mechanism for the FDA and EMA to jointly consider, and exchange views with applicants, on scientific questions during the development phase of hybrid/complex generic ...

In a promising move to tackle the escalating costs of prescription drugs, a new initiative known as the Limited-Competition Generic Market Priority Review Voucher (LCGM PRV) Program is making waves.

The goal of the new pilot program is to allow FDA and EMA assessors to concurrently exchange their views with applicants on scientific issues during the development phase of complex generic drug ...

Recognizing the boon to drug development and product market entry, Congress has expanded the PRV program twice to include rare pediatric diseases and material threat medical countermeasures.