FDA Announces Availability of Guidance on COVID-19 Container Closure System and Component Changes for Glass Vials and Stoppers - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Announces Availability of Guidance on COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers  Today, the U.S. Food and Drug Administration is announcing the availability of a guidance for industry entitled, "COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers." FDA is issuing this guidance to convey recommendations to drug manufacturers regarding the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered through injection or other non-oral routes. This guidance also discusses pathways available to application holders to obtain Agency feedback regarding such planned changes. Additionally, this guidance discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers. This guidance does not apply to CCS types other than glass vials and stoppers.   Many FDA-regulated human drugs (finished pharmaceuticals and biological products) related to, and products being developed for, the treatment and prevention of COVID-19 use glass vials and stoppers as their primary CCS. The supply of CCS components for FDA-regulated products generally may become constrained as manufacturers respond to the public health emergency related to COVID-19. As a result, manufacturers of FDA-regulated products may need to update their approved applications to make changes to CCS components to meet current product demand or increase supply resilience. In response to this public health emergency, FDA will consider risk-based approaches to facilitate implementation of chemistry, manufacturing, and controls (CMC) changes to a CCS in an effort to mitigate the disruptive effect of the COVID-19 pandemic. These measures may include, but may not be limited to, recommendations for adjustments to submission content and reduction in reporting categories for CMC changes. This guidance is not being issued in response to problems with vials currently used in COVID-19 vaccines. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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