FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates
Uptrend Could Signal Surge In Complex-Generic Approvals
Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.
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FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.
US FDA Commissioner Gottlieb says common diseases need new treatments and argues streamlining trials may pique industry interest.
The meetings are tied to requirements from the 2016 21st Century Cures legislation. They could offer more development certainty for sponsors by allowing informal agreements with the agency on pre- and post-market issues.