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The FDA has issued a final guidance on adaptive clinical trials, reworking its subsection on Bayesian methods and clarifying the extent of pre-specification required for the rules governing adaptations. Read More
Qtrilmet was approved in the U.S. in May under the name Qternmet XR as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Read More
In a move to fend off a generic competitor, Merck hit Accord Healthcare with a patent infringement suit in a Delaware federal court over Accord’s generic version of its blockbuster diabetes drug Januvia (sitagliptin phosphate).
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Federal prosecutors have opened a criminal investigation into whether pharmaceutical companies violated the federal Controlled Substances Act (CSA), which is usually used to prosecute drug dealers. Read More
FDA Principal Deputy Commissioner Amy Abernethy announced on Tuesday that the agency will clarify its regulatory approach to cannabidiol products in light of the increasing illegal marketing of CBD products as FDA approved.
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The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Rockwell Medical of Wixom, Michigan over its web page for Triferic (ferric pyrophosphate citrate), an iron-replacement for adults with hemodialysis-dependent chronic kidney disease.
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