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Alston & Bird Health Care Week in Review - May 2021 #4 | 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. ....

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Alston & Bird Health Care Week in Review - May 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, 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On May 19, 2021, the Food and Drug Administration (FDA) issued draft guidance entitled,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 The draft guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic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 Melli ....

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Alston & Bird Health Care Week in Review - May 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, HHS announced several efforts to boost COVID-19 vaccination rates in the U.S. Read more about these initiatives and other news below.
I. Regulations, Notices & Guidance
Event Notices
May 11-12, 2021: The Food and Drug Administration (FDA) announced a public meeting entitled,
Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the subcommittee is to provide advice and recommendations to FDA on regulatory issues. ....

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Alston & Bird Health Care Week in Review - April 2021 #5 | 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 released its FY 2022 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Rates Proposed Rule. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
On April 26, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators. FDA is publishing this draft guidance to help sponsor-investigators with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) f ....

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Alston & Bird Health Care Week in Review - April 2021 #4 | 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, HHS announced it is providing $150 million to community-based health care providers to aid their response to COVID-19. Read more about this funding and other news below.
I. Regulations, Notices & Guidance
On April 21, 2021, the Department of Health and Human Services (HHS) issued a final rule entitled,
National Vaccine Injury Compensation Program: Rescission of Revisions to the Vaccine Injury Table. This action rescinds in its entirety the rule entitled “National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,” published in the Federal Register on January 21, 2021. ....

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