Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?
New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific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.
You may also be interested in...
Supplemental Filings: Gene Therapy Harmonization Moving Ahead; US FDA’s COVID-19 EUA Authority Hanging Around
Peter Marks suggests the need for a ‘compromise’ on gene therapy. Elizabeth Sadove looks towards an extended tenure for COVID products under EUAs.
With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.
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.