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The federal government is proposing to update Medicaid’s National Drug Rebate Agreement to reflect legislative and regulatory changes that have taken place since it was issued in 1991. Read More
A federal appellate court is remanding a False Claims Act suit that alleges Fresenius overcharged Medicare for dialysis treatments — ruling that the whistleblower lacked standing based on a reliance on secondhand accounts. Read More
A federal judge awarded the Federal Trade Commission its request to dismiss a pay-for-delay suit that alleges Endo Pharmaceuticals blocked the market entry of Opana ER and Lidoderm generics. Read More
Sen. Chuck Grassley (R-Iowa) is continuing his investigation into Mylan’s ballooning pricing of the EpiPen and government rebates that it has received, requesting more information in the latest of a series of letters to manufacturer and several federal agencies. Read More
With just over a month until new FDA regulations take effect mandating that all electronically submitted application data conform to a standardized format, the organization responsible for setting those standards is working to train industry to meet the requirements, and is considering developing more frequent and granular updates to those standards in the future. Read More