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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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Calculated Risk: Kansas City Fed: Tenth District Manufacturing Activity Increased in February


The Federal Reserve Bank of Kansas City released the February
Manufacturing Survey today. According to Chad Wilkerson, vice president and economist at the
Federal Reserve Bank of Kansas City, the survey revealed that Tenth District manufacturing
activity climbed higher in February compared to a month ago and a year ago, and expectations
for future activity increased.
“Regional factories reported higher activity in February,” said Wilkerson. “Most businesses
reported more production and shipments, despite some difficulties due to the extreme weather
events recently. However, rising materials prices and shipping delays have negatively affected
85% of firms.”
.
The month-over-month composite index was 24 in February, up from 17 in January and 14 in December. The composite index is an average of the production, new orders, employment, supplier ....

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