Day: March 1, 2018

Today FDA released an addendum to ICH E6 (R2), the GCP Guidelines, to include several provisions for quality management responsibilities of the sponsors of clinical trials. These additional requirements apply to any trials conducted under an IND or IDE and used to support a US market approval application. Some important additions include a whole section … Read more

Last week FDA announced that it is modernizing multiple aspects of its review processes in an effort to make quick decisions, work collaboratively with sponsors and take patient perspectives into consideration for clinical trial design and market approval decisions. To provide examples of its new approach FDA released five new Guidance Documents for neurological disorders … Read more