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House Energy and Commerce to Hold Hearing on Drug Pricing Legislation Senate Senators Thune and Carper Reintroduce Bill on Chronic Disease Management Administration Biden Administration to Divert Raw Materials for COVID-19 Vaccine and Provide Other Supplies to India CDC Issues New Guidance for Vaccinated Americans FDA Panel Votes to Keep Tecentriq on the Market FDA to Propose Menthol Ban in Next Year HHS Will Distribute $1 Billion for Community Health Centers HHS Removes Some Prescribing Barriers for Buprenorphine Final Rules CMS Extends Comprehensive Joint Replacement Model Demonstration for Three Years Proposed Rules CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals ....
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of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators. FDA is publishing this draft guidance to help sponsor-investigators with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) f ....