FDA: API source changes made to fix cGMP issues require new bioequivalence data
In a hypothetical case study, FDA staff said if original API batches were produced at facilities with unresolved cGMP deficiencies, data generated with those batches are unreliable and applicants should run new BE studies with material from the new API source.
The full story
In a hypothetical case study presented by Paramjeet Kaur, the applicant had conducted BE studies on the highest strength and requested waivers for lower strengths, but the agency subsequently found the original API's DMF had unresolved cGMP deficiencies. Kaur said that when the quality of the bio‑batch cannot be assured, "the BE studies and the waiver requests cannot be deemed adequate."
Sign up to keep reading.
Your free newsletter brings you what your city council, county, and school board discussed and decided.