FDA Met Biosimilar Review Timelines But Missed Meeting Goals In 2015
Executive Summary
Agency's biosimilar meeting workload rose slightly; shifts in types of meetings may reflect maturation of individual biosimilar development programs.
You may also be interested in...
ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines
US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.
ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines
US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.
US FDA's Oncology Division Wants To Know About Your Pipeline, Not Just Your NDAs
Oncology Center of Excellence Director Richard Pazdur says agency invites sponsors to present about molecules under development to learn more about future plans.