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The FDA rapped Fresenius Kabi for batch discrepancies and contamination issues, among other quality lapses, following an inspection of its Melrose Park, Ill., facility. Read More
The U.S. Department of Justice (DOJ) announced that three members of a Miami-based research center have been charged for allegedly running a years-long scheme to falsify clinical trial data for profit. Read More
In the wake of the reauthorization of the Generic Drug User Fee Amendments (GDUFA), the FDA has updated its guidance for prior approval supplements (PAS) and amendments for abbreviated new drug applications (ANDA) under GDUFA III. Read More
The Department of Health and Human Services (HHS) will have to come up with a plan to force down the cost of prescription drugs under an executive order signed by President Biden on Friday. Read More