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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
The Innovative Compounding Pharmacy (ICP) has received a warning letter after an inspection revealed misbranded and adulterated drug products. Read More
A group of bipartisan lawmakers have called on Mylan to repay the Department of Defense (DoD) for overcharging the military at retail pharmacies for its emergency allergy treatment, the EpiPen. Read More
The U.S. Supreme Court has paved the way for non-cash patent settlements to trigger antitrust scrutiny after it refused to hear a case involving GlaxoSmithKline’s epilepsy therapy Lamictal. Read More
The FDA has made several amendments to the requirements for filing citizen petitions and petitions for stay of action when used to delay ANDA applications. Read More