Can The FDA Climate Be Too Good?
US FDA’s decision to accept Amicus’ migalastat NDA without a new study is the latest sign of the positive climate for rare disease drugs at FDA. But will it be remembered as a turning point?
You may also be interested in...
Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study. Additional information includes European submission data and post-launch RWE.
US president hit on his sentiments of faster drug approval times and deregulation, signaling FDA could be in for period of sustained criticism.
The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.