Compliance

The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.

Biocon Biologics has announced a change in regulatory status for a manufacturing plant in Malaysia that could pave the way for a pair of long-awaited FDA biosimilar approvals, after similar positive news for an Indian site late last year.

Royal Philips is at the forefront of the driving environmental sustainability along the Scope 1-2-3 chain. The company hosted a round table in Amsterdam to hear experiences from providers.

“What a mess! … The MDR is a complete disaster,” critics tell European Commission.

With so many discussions around future change now in the medtech regulatory melting pot as 2025 kicks off, it is unsurprising to see an intense calendar of EU meetings ahead. But which topics deserve the most focus?

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.

Final guidance on remote and hybrid good manufacturing practice inspections from the global inspectorate body, the PIC/S, aims to enhance inter-agency communication, improve reliance on inspections and ensure efficient use of global resources.

Clinical trial sponsors should strive to strike a balance between privacy and transparency at the very beginning of a trial to be successful, advises Certara’s Honz Slipka.

Two transparency experts share best practices for writing clinical study reports to protect patient privacy.

Staburo’s Kathi Künnemann examined the utility of artificial intelligence in developing plain language summaries for clinical trials results.