North America

The Health and Human Services general counsel referred the online health platform to the Justice Department to investigate potential violations of the Food, Drug and Cosmetic Act after the firm announced it would offer a compounded version of Novo Nordisk’s oral Wegovy.

Richard Pazdur plans to remain involved in drug development after leaving the FDA.

Obesity will continue dominating the cadiovascular, renal and metabolic field in 2026, but the US FDA's Commissioner's National Priority Voucher program could disrupt the user fee calendar throughout the vast sector.

As the FDA sees another quarter with a net loss of employees in CDER and CBER, Pink Sheet editors discuss the potential impact and where it could manifest.

Canada is looking to expedite the review of certain drug classes by tapping trusted foreign regulators in a bid to get new medicines to patients sooner.

Canada’s health care products regulator is seeking to strengthen its oversight of decentralized clinical trials.

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.