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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
The FDA should issue guidance on orphan drug development that provides a detailed set of deadlines and clarity on what exactly will be discussed at various meetings throughout the approval process, according to an industry trade group. 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
For the third year in a row, pharmaceutical companies are filing more proposals with the European Medicines Agency’s pediatric committee seeking approval for the development of drugs for children. 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
Generic-maker Mylan has launched a version of Bristol-Myers Squibb's advanced ovarian carcinoma drug Paraplatin Injection in 50 mg/5 ml multidose vials. 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