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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, the Senate Finance Committee discussed making permanent COVID-19 flexibilities, including those related to telehealth. See the hearing and other news below.
I.Regulations, Notices & Guidance
On May 19, 2021, the Food and Drug Administration (FDA) issued draft guidance entitled,
Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. The draft guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus. These medical de
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This week four experts testified at a US Senate committee about the impacts of personal protective equipment (PPE) and drug shortages during COVID-19, the effectiveness of the Strategic National Stockpile (SNS), and what kind of steps leaders must take to be better prepared for the next public health emergency.
The group spelled out the situation and the consequences of fragile supply chains before the Senate Committee on Homeland Security and Governmental Affairs hearing, COVID-19 Part II: Evaluating the Medical Supply Chain and Pandemic Response Gaps. Today we are in the final miles of the pandemic, but our public health crisis isn t completely over, said one of the experts, Shereef Elnahal, MD, president and chief executive officer of University Hospital in Newark, New Jersey.