FDA neuroscience program launches with Alzheimer’s prevention focus
The initiative brings together agency expertise to address development challenges across brain…
FDA Issues Final Guidance on prescription drug apps and Software
The framework explains how drug companies should handle companion software, prescribing information,…
FDA Launches Rare Disease Framework Initiative
The initiative seeks a more predictable development process that accounts for small…
FDA Reports Charges in Alleged Counterfeit Ozempic Scheme
The federal announcement describes alleged distribution to US sellers and explains how…
FDA seeks public input on ibogaine research
The agency is gathering evidence on early clinical trial design, with patient…
FDA approves first size-adjustable heart valve for children
The approved pulmonary valve can be expanded as children grow, but evidence…