Date: October 1, 2026
Duration: 60 minutes
Format: Teams Meeting
Meeting Description
FDA's draft guidance, Container Closure Systems for Human Drugs and Biological Products, represents the first comprehensive update to the agency's overarching CCS recommendations in nearly 30 years and is currently open for public comment through October 13, 2026. The guidance introduces a risk-based framework for evaluating the quality, suitability, and control of container closure systems across drugs, biologics, combination products, and certain OTC products.
Join colleagues from Pharmaceutical Quality and Regulatory Science for an open scientific discussion to identify key scientific, regulatory, and implementation issues that may warrant comment.
This is intended as a collaborative scientific exchange and does not represent a consensus position of any organization.
Objectives
- Review the scope and major provisions of the draft guidance.
- Identify areas requiring clarification, additional examples, or future guidance.
- Explore impacts on biologics, combination products, generics, and OTC products.
- Capture potential comments and recommendations ahead of the FDA deadline.
Background Materials
The Federal Register notice is here: https://www.federalregister.gov/documents/2026/08/14/2026-16638/container-closure-systems-for-human-drugs-and-biological-products-draft-guidance-for-industry. Click or tap if you trust this link." rel="noopener">Container Closure Systems for Human Drugs and Biological Products (91 FR 52700, 14 August 2026; Docket No. FDA-2026-D-7957). The draft guidance itself is at https://www.fda.gov/media/194220/download. Click or tap if you trust this link." rel="noopener">https://www.fda.gov/media/194220/download.
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Coatesville PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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