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FDA Announces Implementation Of


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In March 2020, because of COVID-19 health risks and travel
restrictions, the Food and Drug Administration (FDA) suspended most
of its inspection program, both in the United States and abroad.
The agency limited inspections to those that were priority or
mission critical, including some pre-approval inspections for
important new therapies and some for-cause inspections. During the
pandemic, FDA also increased its use of some alternatives to
in-person inspections, such as relying on inspections by foreign
regulators and requesting records in lieu of inspection.
1 To
this point, FDA had not embraced real-time video assessments, in ....

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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 monitori ....

United States , David Kessler , Anthony Fauci , Xavier Becerra , Patricia Richman , Rochelle Walensky , Geoffrey Laredo , Timothy Westlake , Janssen Johnson , J Deanna Wilson , James Gelfand , Brian Smedley , Elizabeth Zimmerman , Robertj Fenton Jr , Joseph Nimmich , Christine Yu Moutier , Julie Gerberding , Meiram Mendat , Nicole Lurie , Regina Labelle , Mark Vargo , Industry Committee , National Institute Of Allergy , Health Resources , House Committee On Education , Senate Committee On ,