Neurelis petitions FDA to ensure that any generic version of diazepam nasal spray is no less safe and effective than its Valtoco for all approved uses that remain on the generic label.
House Energy and Commerce Committee ranking member Frank Pallone asks the Government Accountability Office to analyze how FDA paid for its reductions-in-force and whether user fee funds were used legally.
Neurelis petitions FDA to ensure that any generic version of diazepam nasal spray is no less safe and effective than its Valtoco for all approved uses that remain on the generic label.
House Energy and Commerce Committee ranking member Frank Pallone asks the Government Accountability Office to analyze how FDA paid for its reductions-in-force and whether user fee funds were used legally.
A group of academic and public health experts urges FDA to embrace greater transparency, scientific independence and regulatory consistency, arguing that public confidence in the agency has eroded amid concerns over political interference and shifting regulatory standards.
FDA converts the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pediatric patients with locally advanced or metastatic RET fusion-positive solid tumors.
