US FDA To Exercise ‘Maximum Regulatory Flexibility’ For COVID-19 Plasma-Derived Therapeutics

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.