The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One
Between 2010 and 2018, 33.8 percent of the 402 orphan indications approved by the FDA…
Results for "voucher"
Shortening the Review Clock: the Latest on Priority Review Vouchers
The Latest on Priority Review Vouchers Priority review vouchers (PRVs) are a valuable incentive available…
Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway
While the United States market for drugs and biologics targeting tropical or rare pediatric diseases…
Priority Review Vouchers are a Big Carrot for Hungry Companies
Priority review vouchers (PRVs), which are fast-becoming a powerful incentive for drug companies, were originally…
Stacey Ayres
Stacey Ayres Vice President, Regulatory Affairs Stacey A. Ayres, PhD, has more than 20 years...
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The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP
Barry Mangum, Senior Vice President, Pediatrics at Premier Research, talks about the importance of pediatric…
FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease Designation
This is the third installment in a four-part blog series highlighting FDA designations for products…
FDA Designations for Rare Disease Products, Part 1
Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations The FDA offers sponsors…
The Target Product Profile: Your Strategy to Reduce Development and Review Time
Updated on: January 26, 2021 It is a story all too common: A drug product is developed, approved, and…
21st Century Cures Act – Provisions Impacting Pharmaceutical Regulation
On July 2, 2015 the House passed the 21st Century Cures Act . The focus…