Posted by Michael Wonder on 30 Jan 2020
FDA updates prioritization policy for original abbreviated new drug applications, amendments and supplements to maximise impact on public health
30 January 2020 - Today, the U.S. FDA is making critical updates to our policy for prioritising the review of abbreviated new drug applications to advance the public health, efficiently allocate limited agency resources and ensure fairness to applicants, which reflects the FDA’s longstanding practice to prioritise the review of ANDAs that would have the greatest potential impact on public health, if approved.
Under the previous prioritisation policy, roughly half of all ANDA submissions were designated as priority submissions, including many products that could not be marketed for several years as a result of blocking patents or exclusivities.
