North America

The outgoing FDA commissioner, who placed much of the blame for tough calls on small companies that conduct inadequate clinical programs, defended his policy to not overrule center directors, but added that he did not entirely exclude himself from some of the agency's most controversial drug reviews.

At the J.P. Morgan Healthcare Conference, GSK, Sanofi and Pfizer said they are prepared to address questions about vaccines under a new US administration, while former FDA Commissioner Scott Gottlieb warned of threats to public safety.

Novel agents from the biologics center had a median review time of 10.6 months, beating the drugs center's median of 11.8 months thanks to fewer multicycle and more priority reviews.

Review times for all 61 novel agents the US FDA approved in 2024.

If all goes to plan, improvements the national health technology assessment agency wants to make to its drug review procedures – including the tailored, complex and accelerated access reviews – could become effective for applications received in the first half of 2025.

Canada’s health products regulator is inviting feedback on a range of new and revised guidelines and regulatory tools that explain how drug and device companies will be able to comply with significant changes proposed to its shortages framework.

A new methods guide from Canada’s health technology assessment agency should help drug sponsors generate and report appropriate clinical evidence.

The UK’s drug regulator, the MHRA, is exploring new opportunities to work closer with its counterparts from Australia, Canada, Singapore and Switzerland under the ACCESS Consortium group, with a focus on pre-submission scientific advice.