The US FDA wants a smoother transition to newer “low global warming potential” propellants in metered dose inhalers than the prior transition away from CFCs.
The US Food and Drug Administration is planning to transition away from the hydrofluoroalkane (HFA) propellants currently used in metered...
US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.
The complete response letters call for a new trial for PTC’s vatiquinone and more confirmatory evidence for Outlook Therapeutics’ Lytenava, while Telix’s Zircaix CRL shows quality challenges for a novel radiopharmaceutical approach.
Switzerland’s health care products agency said it had cut the time it takes to review marketing applications for certain drugs submitted via its regulatory reliance procedure because it wants to further enhance the appeal of the pathway.
