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.
Leaders of the House Energy & Commerce Committee are asking FDA Acting Commissioner Stephen Ostroff to explain what steps the agency is taking to address safety concerns around the blood thinner Coumadin and its generic version, warfarin. Read More
HHS Wednesday proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
Requiring drug compounders to provide information on all products taken by a patient that may be “suspect” in an adverse reaction would be unduly burdensome, necessitating full access to a patient’s medical records, the International Academy of Compounding Pharmacists says. Read More
The European Medicines Agency’s medical literature monitoring service kicked into full operation Tuesday, allowing drugmakers to easily search for information on adverse reactions associated with their products. Read More
Mylan scored a potential win from the U.S. Patent and Trademark Office when it agreed to review challenges to two patents on Teva’s blockbuster multiple schlerosis drug Copaxone. Read More
The European Medicines Agency expects to receive the first generic drug application under a program that lets companies file joint submissions in the EU, Australia, Canada, Taiwan and Switzerland during the fourth quarter of this year. Read More
Just days before Sandoz is expected to launch Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the FDA issued a proposed rule changing both drugs’ official names, at least temporarily. Read More