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The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends. Read More
Sen. Charles Grassley (R-Iowa) wants the Department of Justice to provide details on a settlement Mylan reached to resolve claims that the company misclassified its epinephrine auto-injector EpiPen for the Medicaid Drug Rebate program. Read More
The Office of Generic Drugs topped last year’s approval and rejection rates, issuing 835 tentative or full approvals and 1,725 complete response letters in fiscal 2016. Read More