user fees – Talk Bio

Despite Government Shutdown, Companies Still Plan to Submit FDA Applications

2 weeks ago talkbio0Tagged AbbVie, amgen, Application procedure, biology (field), drug applications, funding lapse, Government, J&J, Myers Squibb, Pfizer, pharmaceutical delays, shutdown, United States Food and Drug Administration, user fees

FDA shutdown; new drug applications; biologic applications; user fees; pharmaceutical delays; government funding lapse; AbbVie; Amgen; Bristol Myers Squibb; J&J; Pfizer

US Government Shutdown Threatens to Stress an Already Depleted FDA

2 weeks ago talkbio0Tagged delays, Drug Approval, federal funding, Government Shutdown, public health medicine (field), regulatory, Staff, Surgical aspects, United States Food and Drug Administration, user fees

Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays

FDA Chief Calls for Lower User Fees as PDUFA VIII Negotiations Begin

3 months ago talkbio0Tagged Drug Approval, fee structure, Mediation, PDUFA VIII, regulatory policy, United States Food and Drug Administration, user fees

FDA; user fees; PDUFA VIII; regulatory policy; drug approval; fee structure; negotiations