Standards & Regulation

Is research into orphan diseases on the rise?

EMA’s pilot project continues. Is the future of regulation adaptive?

Pathways designed to bring medicines to market faster in Europe are not delivering the goods

Sitting Down With… William Chin, Executive Vice President, Scientific and Regulatory Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA).

Biologic medicines present unique challenges for pharmacovigilance. And with biosimilars hitting the market, life just got more complicated.

Will FDA fast review and voucher incentives make a difference?

Quick fire Q&A with Hans-Georg Eichler, Senior Medical Officer, EMA

With an EMA pilot scheme underway it looks likely that adaptive licensing will feature in the future drug development landscape.

The US is finally introducing regulation on drug serialization and traceability, but gaps remain that could leave patients vulnerable.

An FDA Warning Letter can be a real wake up call. How can you address the root of the problem?