Practical implication
PV teams should update their workflows, especially those related to regulatory intelligence monitoring, to incorporate insights from the workshop and adjust their compliance controls to align with the new FDA guidance on bioequivalence for topical and transdermal drugs.
The FDA is hosting a virtual workshop on September 10, 2026, focusing on modernizing bioequivalence (BE) approaches for topical and transdermal generic drug products. This initiative aims to improve regulatory science funding and provide guidance on submission processes and methodologies for assessing bioequivalence in these complex product categories.
What changed: The FDA has introduced updated guidance and recommendations on bioequivalence for topical and transdermal products. This includes highlighting the use of GDUFA-funded research to support the development of both general and product-specific guidances. Recommendations will address the need for in vivo studies and potential alternative approaches in BE assessments.
Why it matters: These updates are crucial for regulatory affairs professionals and drug developers involved in creating topical and transdermal generics, as understanding and adhering to these new guidelines can streamline product development and reduce submission deficiencies.
Practical implication: PV teams should update their workflows, especially those related to regulatory intelligence monitoring, to incorporate insights from the workshop and adjust their compliance controls to align with the new FDA guidance on bioequivalence for topical and transdermal drugs.
View original source
- Source: FDA - What's New Drugs RSS
- Published at source: 2026-09-11T00:00:00.000Z
- Discovered by monitor: 2026-09-11T21:31:17.969Z
Published from the regulator source ingestion pipeline after PV impact triage.
