FDA up­dates Covid-19 clin­i­cal tri­als guid­ance to ad­dress se­ri­ous ad­verse events

The FDA last week up­dat­ed its guid­ance on con­duct­ing clin­i­cal tri­als amid the coro­n­avirus dis­ease pan­dem­ic to ad­dress how and when spon­sors and ap­pli­ca­tion hold­ers should re­port se­ri­ous ad­verse events (SAE).

The lat­est up­date to the guid­ance comes just days af­ter FDA added new ques­tions and an­swers to the doc­u­ment ad­dress­ing the use of al­ter­nate lab­o­ra­to­ry or imag­ing cen­ters, video con­fer­enc­ing and post­mar­ket­ing stud­ies.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER