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, President Biden unveiled a $2.25 trillion infrastructure and tax proposal called the American Jobs Plan. Read more about the plan and other news below.
I. Regulations, Notices & Guidance
On March 30, 2021, the Department of Health and Human Services (HHS) issued its Semiannual Regulatory Agenda. HHS is the Federal government s lead agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS enhances the health and well-being of Americans by promoting effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public hea
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 announced additional funding to support the 2021 Special Enrollment Period (SEP) for Marketplace health coverage. Read more about the announcement and other news below.
I. Regulations, Notices & Guidance
On March 4, 2021, the Food and Drug Agency (FDA) issued guidance entitled,
COVID-19 Container Closure System and Component Changes. FDA is issuing this guidance to collate recommendations for appropriate reporting category and the content of post-approval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new
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 new actions to expand COVID-19 testing capacity across the country. Read more about the announcement and other news below.
I. Regulations, Notices & Guidance
On February 18, 2021, the Food and Drug Administration (FDA) issued a notice entitled,
Guidance Documents Related to Coronavirus Disease 2019; Availability. The FDA is announcing the availability of FDA guidance documents related to the COVID-19 public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this noti