Building a modern generic drug review process

Acting FDA Commissioner Stephen Ostroff, MD, notes that recent hearings on Capitol Hill highlighted the issue of access to quality, affordable medicines, in particular generic drugs. “FDA’s generic drug program promotes access to quality affordable medicines by reviewing Abbreviated New Drug Applications (ANDAs),” says Ostroff, “the pathway that allows generic drugs to come to market.” FDA is currently working to efficiently process and approve generic drug applications, at record or near-record levels, so when drug patents expire, less expensive generic options are available.