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COVID-19 Medical Products Supply Chain Week in Review – March 2021 #2 | Alston & Bird

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In the past week, Johnson & Johnson and Merck agreed to cooperate on production of the Janssen vaccine, and the Biden Administration used the Defense Production Act (DPA) to facilitate the arrangement. In addition, the GAO issued a report on the FDA’s inspection challenges. Please see details for these supply chain developments below:
On March 2, President Biden announced that Johnson & Johnson and Merck will cooperate to expand the production of the Janssen vaccine, and the Administration invoked the DPA to equip two Merck facilities to meet the standards necessary to manufacture the vaccine. He added that the Administration will continue to use the DPA to expedite critical materials in vaccine production, such as equipment, machinery, and supplies. He projected that the U.S. is on track to have enough vaccine supply for every adult in the U.S. by the end of May. ....

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

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), ....

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