New US FDA Generics Director Praises Industry, Encourages Partnerships
Executive Summary
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.
You may also be interested in...
House Committee Clears Bills To Prevent Pay-For-Delay Deals, Assure Generic Access To Samples
Legislation on patent settlement agreements will not be retroactive; CREATES Act amended to give brand companies affirmative defense to litigation.
US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals
Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.
Let's Get Real – ANDA Approval Likely Takes More Than Two Years, US FDA Says
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.