ARTICLE | Politics & Policy
FDA speeds review of "sole-source" generic competitors
March 17, 2016 1:04 AM UTC
FDA's Office of Generic Drugs (OGD) implemented a policy that would allow expedited review of ANDAs for "sole-source" generics that would compete with only one other approved generic. FDA already provides expedited review of the first generic competitor to an innovator drug.
According to the (see BioCentury Extra, March 3). ...