EMA Creates Pediatric Drug Pilot Project
The agency launches initiative to stimulate pediatric drug development.
The European Medicines Agency (EMA) has announced the launch of a one-year pilot project that offers free interactive meetings with drug developers to discuss the potential for a drug’s use in pediatric patients before submission of a pediatric investigation plan (PIP). Pharmaceutical companies in the European Union that develop new drugs must also develop the drug to treat pediatric patients, and EMA’s Paediatric Committee (PDCO) must approve these PIPs.
During PIP assessments, EMA has found issues with the integration of adult and pediatric drug-development programs submitted by pharmaceutical companies causing potential delays in getting those drugs to children who need them. EMA hopes this pilot project will help developers optimize their drug-development programs and, therefore, speed up pediatric access to the medicine.
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
