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The FDA sent a warning letter to Global Pharmacy Plus, an internet pharmacy, concerning the company’s marketing of generic versions of the immunosuppressant drugs mycophenolate mofetil and tacrolimus, both of which carry Black Box warnings and must only be distributed under an approved Risk Evaluation and Mitigation Strategy (REMS). Read More
Two final documents from the FDA outline a standardized structure and language for risk evaluation and mitigation strategy (REMS) documents to make them more clear and consistent and submissible in Structured Product Labeling (SPL) format. Read More
Medicare Part B patients are having to pay more for their drugs because the Centers for Medicare & Medicaid Services (CMS) process for overseeing data on the average sales price (ASP) of medications is inadequate, the HHS Office of Inspector General (OIG) says in two reports released this week. Read More
The FDA has extended its review of Phathom Pharmaceuticals’ new drug application (NDA) for vonoprazan, an acid-blocking drug used to treat erosive esophagitis, a severe form of acid reflux that damages the lining of the esophagus. Read More
The International Council for Harmonization (ICH) has released a first draft of a new guideline that offers parameters for bioequivalence (BE) studies of immediate-release solid oral drugs, including considerations for selecting study participants. Read More
The FDA is facing serious challenges as it seeks to build criminal investigations into illicit FDA-regulated products, says Catherine Hermsen, FDA Assistant Commissioner for Criminal Investigations, who stepped down at the end of the year. Read More