The US Food and Drug Administration (FDA) has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a negative decision at the division level, detailing which issues are not fit for reconsideration and how many such disputes the agency will be able to handle.
On 10 January, FDA published a draft guidance laying out its plans on how and when sponsors who have been denied an abbreviated new drug application (ANDA) can have that decision reconsidered at the division level. It updates similar guidance from 2017…
