• Regulatory NewsRegulatory News

    ICH details milestones reached on guidelines after Athens meeting

    The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clinical trial data to the pediatric populations.   The ICH announcement follows its 21-25 May meeting in Athens, Greece which was held in a hybrid format. The meeting included seven working groups, as well as the ICH Management Committee...
  • Regulatory NewsRegulatory News

    ICH Transparency: New Info on Funding, Expert Working Groups

    The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded. "While these experts represent the regulatory and industry association parties that nominate them, this new level of transparency will bring a novel understanding of who contributes to the development of guidelines as well as the roles they play," ICH said. Accord...
  • Regulatory NewsRegulatory News

    FDA Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance

    The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials. The addendum, E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population , is intended to supplement ICH's E11 guidance by expanding  the discussion on issues related to pediatric clinical trials in light of scientific and regulatory ...