We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel concluded last week, instead urging the agency to require postmarket observational studies. Read More
A Massachusetts insurer filed a lawsuit this week against Takeda and Eli Lilly in the U.S. District Court for the Western District of Louisiana for allegedly hiding cancer risks of its type 2 diabetes drug Actos. Read More
The FDA chided Citius Pharmaceuticals for a webpage promoting its product Suprenza that omits risk information and makes overblown claims about the weight loss drug. Read More
Companies throughout the drug supply chain that encounter suspected counterfeit products should file a report with the FDA and any affected trading partner within 24 hours, the agency said. Read More
The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More
Drug and biologic manufacturers have one year to update their systems and begin submitting adverse event reports electronically to the FDA instead of via paper. Read More
British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following good manufacturing practice guidelines. Read More
Drugmakers may distribute new risk information to physicians on approved products if they meet a set of standards around the validity of the information, the FDA said in its latest effort to relax limits on the distribution of journal articles and other texts to prescribers. Read More
The City of Chicago has sued five manufacturers of opioid painkillers, alleging the firms improperly marketed the addictive drugs for chronic, non-cancer-related pain management, a practice that elevated the city’s addiction rate and resulted in millions of dollars of unnecessary payments. Read More
House lawmakers advanced an FDA funding package that directs the agency to address a multitude of controversial issues, including justifying the costs to generic drugmakers of the agency’s proposed labeling overhaul. Read More
The U.S. Food and Drug Administration has released a proposed rule allowing it to destroy certain drug imports that have been refused entry into the U.S. — the latest attempt to boost the integrity of the U.S. supply chain. Read More