Eight years lat­er, FDA re­vis­es draft guid­ance on pe­di­atric clin­i­cal phar­ma­col­o­gy stud­ies

The FDA on Wednes­day re­leased up­dat­ed draft guid­ance fo­cus­ing on how spon­sors of new drugs and bi­o­log­ics can best iden­ti­fy the ap­pro­pri­ate pe­di­atric dos­es of their de­vel­op­ing prod­ucts, as well as how to use dis­ease and ex­po­sure-re­sponse knowl­edge from pri­or stud­ies to in­form fu­ture pe­di­atric de­vel­op­ment.

The new 25-page draft guid­ance builds on a ver­sion from 2014 and pub­lic com­ments, the agency said, ex­pand­ing on the sec­tion around eth­i­cal con­sid­er­a­tions for con­duct­ing such stud­ies, and adding a sec­tion on drug-drug in­ter­ac­tions, as well as gen­er­al­ly tweak­ing the writ­ing and or­ga­ni­za­tion of the orig­i­nal draft.

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