Bass, Berry & Sims attorneys Clint Hermes, Heather Pearson and Angelique Salib authored an article for LexisNexis outlining the legal considerations in conducting clinical trials abroad. It covers U.S. and foreign rules, regulations, and guidance that manufacturers should consider when designing and conducting them. Among the topics addressed are reasons for conducting clinical trials abroad, requirements for FDA acceptance of foreign clinical data, data protection and anti-bribery laws, export controls, and foreign laws governing the conduct of clinical trials.
The article, “Geographic Considerations in International Clinical Trials,” was published as part of the Practice Guidance series by LexisNexis and is available online (subscription required).
The content was summarized by Law360 on April 6, titled “Key Guidelines For Conducting Clinical Trials Overseas,” and is available online.