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.
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for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations.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
A bill reauthorizing the FDA’s user fee agreements for the next five years and restructuring fees for biosimilars, including the first year of clinical trials, became law Aug.18 when President Trump signed it. Read More
A federal court invalidated five Mallinckrodt Pharmaceuticals patents on its Inomax respiratory treatment system in response to the company’s own lawsuit against Praxair. Read More
Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at the RAPS’ 2017 Regulatory Convergence meeting. Read More