Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails

Alternative therapies designed to avoid, eliminate, or reduce the use of opioids may be eligible for Breakthrough Therapy Designation or Priority Review, the US FDA draft guidance says.

While drug regulators are “conservative” by nature, the European Medicines Agency wants to help companies rather than rip their dossiers “into little pieces,” a senior regulatory assessor says.

Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.

CDER Director George Tidmarsh said in a now deleted social media post that his center will evaluate surrogate endpoints. Tidmarsh mentioned "notable failures," including a lupus drug, where he has past business connections to the sponsor's board chair.