North America

US FDA Commissioner nominee Martin Makary told Senators that he plans to review the data on the abortion pill mifepristone, raising some lawmakers concerns that older safety requirements the FDA has deemed unnecessary, like in-person dispensing, may be reinstated.

Martin Makary said he would re-evaluate the topics that deserve a Vaccines and Related Biological Products Advisory Committee review, but did not commit to rescheduling the cancelled meeting on influenza vaccine strain selection.

Congress continues to offer broad support for encouraging alternatives to opioid pain medicine, including proposals to speed coverage of new agents like Vertex’ Journavx.

Acting Commissioner Sara Brenner rejected the company’s request for a hearing, saying the lack of an adequate and well-controlled trial showing tasimelteon's effectiveness in treating sleep-onset insomnia is “fatal to the application.”

Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.

As part of efforts to modernize its clinical trials framework, the Canadian regulator is looking to better facilitate expanded access clinical trials, which allow investigational drugs to reach patients with serious conditions before they are approved.

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

A new collaboration of health technology appraisal bodies in the US, England and Canada could lead to better alignment on HTA methodology in the future.