EMA to revoke PIP class waivers in oncology; says more cancer trials needed in children
This article was originally published in SRA
The European Medicines Agency's paediatrics committee (PDCO) is planning to revoke class waivers for paediatric investigation plans (PIPs) in some conditions on the grounds that the waivers are preventing the agency from requesting studies in children, especially in the field of oncology1,2.
You may also be interested in...
Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.
The Australian health care products regulator is inviting feedback on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices.
A draft EU guideline explains how companies can ensure that data from ongoing clinical trials remains relevant for regulatory decision-making despite problems posed by the COVID-19 pandemic.