Alston & Bird Health Care Week in Review - April 2021 #3 | A

Alston & Bird Health Care Week in Review - April 2021 #3 | 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, President Biden signed a bill extending a moratorium on Medicare sequestration through the end of 2021. Read more about the law and other news below.
I. Regulations, Notices & Guidance
On April 15, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. FDA is issuing this guidance to describe how the agency will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.

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