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Alston & Bird Health Care Week in Review – March 2021 #1


Below is Alston & Bird’s Health Care Week in Review , which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news. Week in Review Highlight of the Week:

This week, CMS announced additional funding to support the 2021 Special Enrollment Period (SEP) for Marketplace health coverage. Read more about the announcement and other news below.

I. Regulations, Notices & Guidance On March 4, 2021, the Food and Drug Agency (FDA) issued guidance entitled, COVID-19 Container Closure System and Component Changes . FDA is issuing this guidance to collate recommendations for appropriate reporting category and the content of post-approval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) 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 parenterally. This guidance also discusses pathways available to application holders to obtain Agency feedback. Additionally, this guidance discusses risk-based tools available to facilitate […]

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