Mer­ck and PhRMA to FDA: Wait for ICH be­fore fi­nal­iz­ing guid­ance on tox­i­c­i­ty test­ing for can­cer drugs

Drug­mak­ers and in­dus­try groups are call­ing on the FDA to hold off on fi­nal­iz­ing a draft guid­ance un­til the In­ter­na­tion­al Coun­cil on Har­mon­i­sa­tion (ICH) fi­nal­izes its own guid­ance on the top­ic of re­pro­duc­tive tox­i­c­i­ty test­ing for on­col­o­gy drugs.

Com­ments were re­leased last week on the FDA draft guid­ance from late Sep­tem­ber.

In­dus­try group PhRMA and Mer­ck both called on the FDA to en­sure con­sis­ten­cy be­tween the draft guid­ance and rel­e­vant ICH guide­lines, and urged FDA to wait un­til ICH S5(R3) is en­dorsed at Step 4 of the ICH process.

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