drug applications
Despite Government Shutdown, Companies Still Plan to Submit FDA Applications
FDA shutdown; new drug applications; biologic applications; user fees; pharmaceutical delays; government funding lapse; AbbVie; Amgen; Bristol Myers Squibb; J&J; Pfizer
FDA Begins Publishing Complete Response Letters for Ongoing Drug Applications in Real Time
FDA; complete response letters; real-time disclosure; drug applications; radical transparency; pending applications; regulatory transparency; public health; openFDA