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    Biosimilar Interchangeability Problems Pose Complex Challenge for Regulators

    An emerging class of biological products intended to act as the generic equivalents of earlier, branded products is being threatened globally by an obvious, yet complex set of issues, say two experts consulted by Regulatory Focus . The products-known as biosimilars, follow-on biologics or subsequent entry biologics-are intended to act as interchangeable substitutes for other biological products whose patents have expired and are thus eligible for market competition. Whi...
  • Feature ArticlesFeature Articles

    Simplify

    "Simplicate, then add lightness."-Colin Chapman, founder of Lotus Cars. I have been a quality professional in the medical device industry for 20 years. During that time, the basic guidance has remained consistent: do not make your quality system procedures too complicated. Even so, I am still surprised at how many professionals try to impress others with complexity. This is almost always a mistake. People are too busy to remember a lot of steps, conditions, exception...
  • EMA Proposes Changes to Existing Clinical Trial Guideline on Multiplicity Issues

    The European Medicines Agency (EMA) is calling for a new guideline on multiplicity issues in clinical trials in a new concept paper released on 30 May. EMA first released a paper on multiplicity issues , which are the array of different variables and factors acting upon and within a study, in 2002. "Since then," writes EMA," it has been proven to be useful for both industry and regulators when planning and assessing confirmatory clinical trials." Further advances in me...