FDA Releases Extractables, Leachables Draft Guidance for Pharmaceuticals
December 02, 2025
December 02, 2025
WASHINGTON, Dec. 2 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration released a draft guidance for industry entitled "Q3E Guideline for Extractables and Leachables," along with a supporting document for Class 3 leachable monographs.
The draft guidance and supporting materials were developed under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The purpose of t . . .
The draft guidance and supporting materials were developed under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The purpose of t . . .