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Waiver confirms that paediatric studies of certepetide in pancreatic cancer are not needed Significant clinical trial burden and costs avoided due to waiver BASKING RIDGE, N.J., May 20, 2024 --...
Waiver confirms that paediatric studies of certepetide in pancreatic cancer are not needed
Imposing the FDA on-label/off-label framework on administratively defined "children" resulted in a regulatory demand for pediatric studies that had no basis in clinical medicine, with the exception of the small group of preterm newborns.
The European Commission has published its long awaited and leaked proposals for a once-in-a-generation revision of the EU general pharmaceutical legislation (GPL).
Yesterday, the European Commission published two legislative proposals concerning the regulation of medicinal products in the European Union. The proposals seek to consolidate existing...