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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of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators. FDA is publishing this draft guidance to help sponsor-investigators with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) for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

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