Communicating early and proactively with FDA appears to improve the likelihood of an earlier approval for a new drug or biologic. Last Friday, FDA released a report commissioned by Booz, Allen Hamilton which shows that:
- 52% of companies that met with FDA at the end of Phase 2 trials received approval during the first review cycle vs. 29% for companies that did not meet with FDA during this period.
- Of 58 new drug products for which manufacturers met with FDA before even submitting the application, nearly half received approval during the first cycle.
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