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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
Endo Pharmaceuticals and Impax Laboratories are facing a lawsuit alleging that the two drugmakers conspired to keep a generic version of Endo’s pain medication Opana ER off the market. Read More
Clinical investigators looking to develop new therapies for children with Gaucher disease may use multi-company, multi-arm trials or data extrapolation techniques, according to a joint strategic plan released by the FDA and European Medicines Agency. Read More
Drugmakers conducting animal trials to support the development of biological and chemical weapon countermeasures should control for animal age, health, weight and physical environment when designing study protocols, the FDA says in draft guidance implementing the Animal Efficacy Rule. Read More
Eight African nations have signed up to participate in the second European & Developing Countries Clinical Trials Partnership, with a ninth expected to follow suit soon. Read More
Bayer HealthCare, Boehringer Ingelheim and Eli Lilly are the latest drugmakers to make more clinical trial data available — in line with a recent push for transparency on the part of European regulators. Read More
Manufacturers of biosimilars should take extra care in designing clinical trials and executing other steps needed to demonstrate that their products line up with reference drugs, according to key FDA draft guidance on creating versions of the complex therapies. Read More