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.

Endpoints News

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.