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Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance
Freyr Regulatory Radio
11 minutes 19 seconds
2 years ago
Season 3: Episode 4 - US FDA’s Facilitated Regulatory Pathway and Their Significance
Expedited drug development pathways ensure the availability of treatment at the earliest. The US FDA’s facilitated Regulatory pathways give priority to innovators based on the nature of their innovation and more. Our experts discuss (i) Fastrack, (ii) Breakthrough Therapy, (iii) Accelerated Approval, and (iv) Priority Review and their impact on drug development timelines.