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.
Recent action from a state legislature, as well as objections from industry groups, suggest the FDA should narrow its guidance for off-label claims, according to two prominent labeling attorneys. Read More
The FDA updated its nearly 15-year-old policy on performing environmental assessments and reviewing potential exclusions under the Office of Pharmaceutical Quality. Read More
Congress is considering giving the FDA authority to regulate over-the-counter products through user fees and administrative action, similar to how it regulates prescription drugs. Read More
Application fees for prescription drug approvals will increase by nearly 20 percent in fiscal 2018, starting Oct. 1, the FDA said in a Federal Register filing. Read More
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for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations.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