regulatory

News

uniQure has revealed that the FDA has said it is not prepared to review its Huntington's gene therapy in what seems to be a change in policy.

R&D

Automation holds the potential to enhance scientific rigour and operational efficiency while solving long-standing regulatory conundrums.

News

The FDA has proposed a radical change to the regulatory requirements for bringing biosimilar medicines to market as a way to cut US drug prices.

News

Insmed gets EU recommendation for first non-cystic fibrosis bronchiectasis therapy Brinsupri, plus other CHMP decisions.

News

The FDA has named the first products to take advantage of its recently announced Commissioner's national priority voucher programme.

News

The regulatory authorities in the UK and US have agreed to work more closely together on the regulation of medical technologies and AI.