The Food and Drug Administration (FDA or Agency) is announcing a pilot program that affords sponsors or applicants who are selected for participation the opportunity to meet with Agency staff to discuss model-informed drug development (MIDD) approaches in medical product development. Meetings under the pilot program will be conducted by FDA’s Center for Drug Evaluation […]

Companies first to deliver integrated, end-to-end, global pediatric drug development and clinical center of excellence EXTON, PA, and MORRISVILLE, NC, DATE – KinderPharm LLC, dedicated exclusively to pediatric clinical research, and Worldwide Clinical Trials Inc. (Worldwide), an award-winning, full-service CRO, today announced they have entered into a strategic alliance to deliver the world’s first single […]

By: Vasum Peiris, M.D., M.P.H. In medicine, knowledge is power and the information and knowledge gained from medical imaging have transformed the way medicine is practiced in less than a generation. Advances in X-ray imaging have evolved dramatically and span simple projection X-ray examinations to sophisticated 3-D techniques (computed tomography or ‘CT’)  to fluoroscopy, which […]

By: FDA Consumer Health Information You may have heard of clinical trials, and your doctor may even have suggested your child enroll in one. Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. If […]

On March 20, 2018 the European Medicines Agency (EMA) and the European Commission organized a workshop to further improve the implemetation of the Paediatric Regulation.  The workshop follows the publication of the Commission’s ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union. The aim of the […]