New US FDA Generics Director Praises Industry, Encourages Partnerships
Refuse-to-receive rates for ANDAs are down, suggesting sponsors better understand the standards for quality applications, Office of Generic Drugs Director Sally Choe says in first speech to industry.
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Legislation on patent settlement agreements will not be retroactive; CREATES Act amended to give brand companies affirmative defense to litigation.
Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.
Office of Generic Drugs Director Kathleen Uhl calls a two-cycle approval timeline a realistic expectation for ANDA approval, but would not say that most ANDAs will fall into the paradigm.