FDA Qualified Infectious Disease Product Designations
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Qualified Infectious Disease Product Designation was introduced in 2012 as a provision of the FDA Safety and Innovation Act to encourage development of treatments for serious or life-threatening infections caused by bacteria or fungi.
You may also be interested in...
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.
BMS Has A Strong Pipeline, But Access Challenges Remain
Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve patients’ access to lifesaving therapies. And the group has several new products ready to roll.