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A New York maker of homeopathic medicines that include toxic ingredients ran afoul of the FDA because it made drug-like claims for its products but did not manufacture them to the standards invoked by the claims, the agency said in a warning letter. Read More
Congress is considering giving the FDA authority to regulate over-the-counter products through user fees and administrative action, similar to how it regulates prescription drugs. Read More
Application fees for prescription drug approvals will increase by nearly 20 percent in fiscal 2018, starting Oct. 1, the FDA said in a Federal Register filing. Read More
Intellipharmaceutics artificially inflated its stock prices during the NDA process for its oxycodone product Rexista, a new class-action lawsuit claims. Read More
Managing drug treatments for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations. Read More
The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Read More
The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. Read More