FDA recommends using imaging of the sinuses as a secondary efficacy endpoint for drugs being developed to treat chronic rhinosinusitis with nasal polyps (CRSwNP).
As technology evolves and medical devices change as a result, creating even more challenges for regulators, clinical trial designs must adapt to the emerging trends.
Sponsors of extra-U.S. trials need to carefully monitor the FDA’s requirements for the submission of foreign data.
The administration’s most recent release clears up what is necessary for developers to successfully approach specialized medical device advisory committee (MDAC) panels.
The Chinese government plans to implement greater scrutiny on the medical device industry with new hefty fines and regulations.