RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    EMA Revises Reflection Paper on Pediatric Extrapolation

    The European Medicines Agency (EMA) on Friday released an updated draft reflection paper for public consultation detailing the agency's framework for pediatric extrapolation in drug development. EMA defines extrapolation as extending information and conclusions from studies of a particular subgroup (source population), condition or drug to make inferences for another subgroup (target population), condition or drug. By extrapolating data from adult or other pediatric popu...
  • Regulatory NewsRegulatory News

    ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation

    The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June. The two topics include the first revision to ICH's 1997 E8 General Considerations for Clinical Trials and a new guideline on pediatric extrapolation in clinical trials, both proposed by the US Food and Drug Administration (FDA). The ICH Assembly also adopted concept papers outlines f...
  • Regulatory NewsRegulatory News

    EMA Drafts Framework for Extrapolating Adult Patient Data for Pediatric Indications

    The European Medicines Agency (EMA) released a reflection paper on Monday with the hope of helping drugmakers avoid unnecessary pediatric research by establishing a framework for extrapolating clinical data from adult patients to support pediatric indications for new drugs. EMA says the framework will help "optimize" clinical trial participation for pediatric patients by using existing data from other populations, including adults and other pediatric subgroups, to predic...
  • Regulatory NewsRegulatory News

    FDA Explains How to Extrapolate Data for Pediatric Medical Devices in New Guidance

    A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices are safe for use in pediatric populations. Background There is often a "paucity of scientific evidence available to substantiate submissions for devices that are indicated for use in the diagnosis or treatment of pediatric patients," FDA explains in the forward of its new draft guidance, Leve...