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Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?

Only Fasting Studies Required For Most Generic IR Oral Solids, Draft Guide States

Executive Summary

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

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US FDA Expands Options For Product-Specific Guidance Meetings With ANDA Sponsors

But so far, even broadening the eligibility beyond the GDUFA III commitment has not prompted any generic drug sponsors to request a meeting with FDA staff about issues created by updated or new product-specific guidances. The size of the request package could be one factor.

Global Harmonization Efforts Must Go Further

With global regulation of off-patent medicines continuing to evolve, IGBA secretary general Suzette Kox talks about the progress expected from regulatory harmonization for generics and a reduced clinical trial burden for biosimilars.

ICH Proposes Harmonized Bioequivalence Standards For Solid Oral Drugs

The first document of a three-part series of ICH guidelines on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms has been issued for stakeholder consultation.

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