North America

ImmunityBio's Patrick Soon-Shiong made several misleading efficacy claims on a podcast and TV ad about the company's cancer treatment, the FDA said in a warning letter.

The threat of Chinese dominance in the prescription drug sector appears to be a strong, unifying theme for legislators heading into the US Food and Drug Administration user fee reauthorization cycle, but two very different sets of policy issues must be addressed.

Payroll costs in the prescription drug user fee program increased in fiscal year 2025 despite the reduction-in-force and voluntary departures, which could impact industry efforts to reduce the annual charges.

The US FDA aims to prevent poor quality or incomplete responses to Form 483 inspection observations with a new draft guidance that describes the structure and content for concise, factual and effective corrective action responses.

Canada’s Drug Agency is also looking to consider the impact on productivity outcomes for both patients and informal caregivers when assessing the value of a drug.

Health Canada has proposed new clinical trial rules aimed at strengthening support for innovative studies and reducing regulatory burden on industry.

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.