Alston & Bird Health Care Week in Review - April 2021 #5 | A

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of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators. FDA is publishing this draft guidance to help sponsor-investigators with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) for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 individualized antisense oligonucleotide (ASO) drug products. ASO drug products that are the focus of this draft guidance are those being developed to treat rapidly progressing, severely debilitating or life-threatening (SDLT) disease attributable to a unique genetic variant or variants that may be amenable to RNA-directed treatment.

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