Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List

There are pending requests to add 13 candidates to the tropical diseases that qualify for a priority review voucher, according to a Pink Sheet analysis, as FDA Commissioner Robert Califf faces congressional pressure on the years since the list's last update.

Mosquito
The FDA has not updated the list of qualifying tropical diseases for the PRV program in almost four years. • Source: Shutterstock

The extended interval between updates to the US Food and Drug Administration’s list of qualifying tropical diseases eligible for a priority review voucher is drawing increased attention from Congress.

The list currently comprises 27 tropical diseases or disease categories and was last updated in July 2020, when the agency...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Review Pathways

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.

Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

New EU Filings

 

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

More from Pathways & Standards

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

New EU Filings

 

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.