USFDA Launches Operation TrialBlazer to Accelerate Drug Development and Clinical Trials
Bengaluru: The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up drug research, from early-stage investigational studies to late-stage trials, under an initiative called Operation TrialBlazer.
The FDA said it is planning a new pilot program that would pair drug sponsors with qualified research institutions such as academic medical centers and contract research organizations to shorten the time from drug identification to first-in-human studies.
It separately updated its guidance for early-stage studies, saying a more phase-appropriate approach could save companies six to 12 months of development time.
In late-stage development, drugmakers may be able to rely on one rigorous, well-controlled pivotal trial plus confirmatory evidence, rather than multiple pivotal studies, for approval.
The agency also launched a webpage to bring together regulatory requirements, guidance and examples in one place, aimed in part at helping smaller companies.
It said a new Phase 1 Contact Center will provide real-time answers on protocols, regulatory requirements and other early-trial questions.
