Clinical Trials
The EU’s draft Biotech Act promises faster clinical trial approvals and innovation incentives, but the industry warns that intellectual property provisions have limited appeal.
A Friends of Cancer Research working group believes “seamless” trial designs could be used more frequently for rare cancer drug development, but advanced planning is key.
Industry representatives raised several concerns about an FDA proposal to charge additional fees to sponsors not conducting Phase I trials in the US, including that the idea could increase the burden of drug development overall.
The UK’s medicines regulator reports promising outcomes from a pilot scheme testing streamlined processes for reviewing low-risk substantial modifications to ongoing clinical trials.