North America

At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.

CMS backs off on a plan to put “guardrails” around manufacturer payments that are excluded from Average Sales Price calculations in Medicare, but is planning to revisit the issue.

The soon-to-be former CDER director will return to the oncology office to complete his FDA tenure, the agency said.

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

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.

Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.