Tag Archives: priority review
The FDA and Congress have established several programs that allow new drug approval based on less evidence, so that patients and their physicians have faster access. However, expedited development and regulatory approval pathways for prescription drugs at FDA present ethical and policy dilemmas.
June 23, 2016
There are a number of challenges that could result from over-expanding the application of voucher incentive programs. Without careful consideration of the impact increased PRVs could have on regulatory review and broader drug development incentives, policymakers’ well-intentioned efforts may...
June 15, 2016
In a positive first step, the House recently proposed adding Zika to the list of diseases in the Food and Drug Administration’s (FDA) priority review voucher (PRV) program. The PRV platform, however, could be used far more proactively to help address future pandemics before they strike.
March 22, 2016
The generics market has been in turmoil---shortages, price spikes, quality issues, compounding abuses---since 2008. What can be done to create a healthy marketplace?
March 21, 2016
Recently an official from the Food and Drug Administration (FDA) expressed concern about the costs to the FDA of the priority review voucher program. But it doesn’t have to be that way, and it’s important to tackle these concerns.
October 28, 2015