In Food and Drug Law Journal, Health Care Attorneys Examine India’s Final Clinical Trial Rules
Health care partner Mark Barnes and associate Minal Caron (both of Boston) authored a follow-up article published in the Food and Drug Law Journal July issue with an update on developments related to India’s 2018 draft clinical trials rules. The original article was published in 2018 titled “The Evolving Regulatory Landscape for Clinical Trials in India.”
The authors examine finalized rules under India’s clinical trial regulatory framework including compensation and medical management, post-trial access requirements, expedited application review, application requirement flexibility, non-compliance penalties and appeal rights, among other topics.