For Sale: FDA Priority Review Vouchers

The Commercial Market For Priority Review Vouchers.

In 2007 the US Congress created the priority review voucher program to encourage the development of drugs for neglected diseases. Under the program, the developer of a drug that treats a neglected disease receives both a faster review of the drug by the Food and Drug Administration and a voucher for a faster review of a different drug. The developer can sell the voucher. We estimated the commer...

Drug and vaccine development for infectious diseases: the value of priority review vouchers.

Introduction of European priority review vouchers to encourage development of new medicines for neglected diseases.

Every year 1 billion people worldwide are affected by traditionally neglected diseases, such as malaria, tuberculosis, leishmaniasis, and lymphatic filariasis, which impose tremendous public health burdens. Governments, foundations, and drug manufacturers have, however, started to support development of new treatments. European Union Member States have been leaders in implementing so-called pus...

Analysis of Neglected Tropical Disease Drug and Vaccine Development Pipelines to Predict Issuance of FDA Priority Review Vouchers over the Next Decade

The need for new drugs and vaccines for neglected tropical diseases (NTDs) is widely accepted [1]. Yet, encouraging pharmaceutical and biotechnology company investment in developing these much-needed treatments remains a challenge due to a lack of a commercial market driving companies to pursue NTD projects [2]. To address this challenge, economists Ridley, Grabowski, and Moe at Duke University...

A Review of FDA Guidance

16.15.03-022010 Introduction Following publication of the December 2008 FDA Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, assessment of cardiovascular safety has become a critical focus during the development of new antidiabetic therapies for Type 2 diabetes mellitus (T2DM). The importance of this guidance docume...