• Regulatory NewsRegulatory News

    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
  • Regulatory NewsRegulatory News

    FDA, with academic and community partners, launches first pediatric ECG warehouse

    Pediatric electrocardiogram (ECG) data being collected by the US Food and Drug Administration are now available in a first-of-kind data warehouse.   The warehouse, a mirror of a similar data warehouse for adult ECG data, collects and makes available a rich store of information “to enhance cardiac safety review for therapeutic product development for children,” according to a new FDA Spotlight article announcing the launch of the warehouse.   One prong of the wo...