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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, 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of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators. FDA is publishing this draft guidance to help sponsor-investigators with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) for certain individual
AustraliaUnited-statesSouth-carolinaTexasPhiladelphiaPennsylvaniaCaliforniaCanadaFranceSan-franciscoAmericanRandy-kellerCDC to Issue Guidelines As Long-Haul COVID Numbers Rise
April 28, 2021 The CDC is finalizing new guidelines for doctors on long-haul COVID-19.
In a daylong congressional hearing Thursday, John Brooks, MD, a medical epidemiologist in the CDC’s Division of HIV/AIDS Prevention, testified that the guidelines were going through the clearance process at the agency.
“They should be coming out very shortly,” Brooks said.
The guidelines, which were developed in collaboration with newly established long-haul COVID-19 clinics and with patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, Brooks said.
CaliforniaUnited-statesAmericansJohn-brooksFrancis-collinsAnna-eshooJennifer-possickNational-institutes-of-healthSubcommittee-on-healthHealth-director-francis-collinsYale-new-haven-hospitalகலிஃபோர்னியா