FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Drugmakers Call for Clarification of FDA’s Postapproval Change Guidance

Dec. 14, 2018
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Leading drug companies called for tweaks in the FDA’s draft guidance on postapproval changes for drugs to help clarify info and better align with ICH guidelines.

Eli Lilly criticized the agency’s recommendations for being “often more conservative and more prescriptive” than current guidance, and claimed they don’t align well with forthcoming ICH Q12 guidelines for managing drug product lifecycles.

“ICH Q12 is recognizing that too many changes require regulatory reporting and often at too high a reporting level, stifling innovation and creating potential global supply challenges,” Eli Lilly said in written comments.

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