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of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators. FDA is publishing this draft guidance to help sponsor-investigators with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) for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