Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research
Executive Summary
ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.
You may also be interested in...
US FDA’s New Generics Chief: We Need More Flexibility For Complex Products
Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.
US FDA’s New Generics Chief: We Need More Flexibility For Complex Products
Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.
AstraZeneca Gets Rare Warning Letter Over Breztri Sales Aid; Footnotes Don’t Balance Graphics
Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.