North America

Drug sponsors should follow FDA guidance to present a separate pediatric safety extrapolation when submitting pediatric study plans, an FDA official said, which could allow for expanded use of novel approaches in pediatric safety testing.

In the wake of recent FDA guidance setting out a streamlined approach to biosimilar approval, developers have spent the past month responding. While most reactions have been enthusiastic, some firms urged caution.

The FDA wants to extend the goal date for some applications with facilities that receive a pOAI classification to allow more first-cycle approvals.

Amgen, BMS, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis and Sanofi will reduce prices of some drugs for Medicaid and offer cheaper prices through direct-to-patient platforms, among other concessions, and receive tariff exemptions.

Regulators in the US and Canada are working together to streamline approval timelines for generic drugs through a voluntary information sharing program.

An early negotiation process for certain cancer drugs could cut pricing negotiation times by up to six months, while a targeted process for non-complex drug negotiations could lead to timelines that are 30–45% faster than standard negotiations.

Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.

Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.