Biosimilar Advisory Committees Will Focus Less On Clinical Data
Executive Summary
FDA wants panels to look more closely at analytics in lesson learned from Zarxio meeting.
You may also be interested in...
US FDA COVID-19 Adcom: What Additional Members Are Needed?
Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application.
Mylan's Herceptin Advisory Committee May Be First Bumpy One For A Biosimilar
US FDA did not address production problems in its briefing document for upcoming Oncologic Drugs Advisory Committee meeting, but manufacturing deficiencies found at Biocon's facility could prompt questions.
Mylan's Herceptin Advisory Committee May Be First Bumpy One For A Biosimilar
US FDA did not address production problems in its briefing document for upcoming Oncologic Drugs Advisory Committee meeting, but manufacturing deficiencies found at Biocon's facility could prompt questions.