FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-re­lat­ed process­es are be­gin­ning to nor­mal­ize: The re­lease of six guide­lines from the In­ter­na­tion­al Coun­cil of Har­mon­i­sa­tion.

Years in de­vel­op­ment, the ICH doc­u­ments of­fer an in­ter­na­tion­al per­spec­tive on drug de­vel­op­ment, with these lat­est guide­lines cov­er­ing every­thing from rec­om­men­da­tions to sup­port the clas­si­fi­ca­tion of drug sub­stances, fea­tured in the M9 guid­ance, to stan­dards for non­clin­i­cal safe­ty stud­ies for pe­di­atric med­i­cines in the S11 guide­line.

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