Today, the Food and Drug Administration Office of Generic Drugs (OGD) posted their Annual Report for calendar year 2016. 2016 marked the highest number of generic drug approvals and tentative approvals ever awarded by OGD–more than 800. These generic drug products have the potential to provide more affordable care to thousands of patients with serious and life-threatening diseases.
OGD continues to improve our review infrastructure, meet all Generic Drug User Fee Amendments (GDUFA) commitments, and promote consistency across all applications and applicants.
Direct link to the report: https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/ HowDrugsareDevelopedandApprove d/ApprovalApplications/ AbbreviatedNewDrugApplicationA NDAGenerics/ucm542710.htm