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Health Care Attorneys Author Article on Evolving Regulatory Landscape for Clinical Trials in India

Practices: Health Care, Health Privacy & Security, Clinical Research, Life Sciences, India, Asia Pacific

Health care partner Mark Barnes and associates Jamie Flaherty and Minal Caron (all of Boston) have co-authored an article in the Food and Drug Law Institute’s Food and Drug Law Journal that describes the significant transformation India has undergone since 2013 in regard to clinical trials regulations.

In 2013, the Indian government – in an effort to bolster its regulatory framework – released a number of new and complex regulations that unfortunately made India an unpredictable jurisdiction in which to site and conduct clinical trials.

The article is a comprehensive treatment of the events and regulatory changes that have shaped India’s clinical trial landscape over the past several years and documents current efforts in India to re-revise and improve its regulation of clinical trials.

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