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The FDA warned a Chinese drugmaker for inadequate testing and quality control for drug supplies and finished products, as well as numerous other GMP violations. Read More
Insys Pharmaceuticals settled with the state of Illinois for $4.45 million to settle a 2016 lawsuit over the company’s deceptive marketing of opioids, the state attorney general announced. 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
The FDA will convene a public meeting of its Pediatric Advisory Committee to discuss the use of opioid cough medicines in treating children, part of the agency’s ongoing efforts to address this issue, FDA Commissioner Scott Gottlieb said Aug. 21. Read More
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More
The FDA is soliciting comments from industry members and shareholders on how direct-to-consumer drug advertising should depict risk information. Read More
A company that warehouses drugs but doesn’t own them fits into a new category to be regulated under a 2013 federal law that aims to tighten security over the drug supply chain by 2023, according to new FDA guidance released Aug. 18. Read More