Our US Food and Drug Administration (FDA) team recently published a blog post discussing the FDA’s issuance of its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health databank. While the authority to issue such notices has existed since the 2007 passage of the Food and Drug Administration Amendments Act, this is the first time the FDA has exercised its clinicaltrials.gov enforcement authority.
Legal Insights and Perspectives for the Healthcare Industry
We invite Health Law Scan readers to join Morgan Lewis for an upcoming webinar series, Privatization of the Vaccine Rollout, which will explore the legal and regulatory issues for businesses that have become increasingly central to rolling out vaccines in the United States and around the globe.
Members of our healthcare team recently published a LawFlash highlighting the American Rescue Plan Act of 2021 (ARPA). ARPA provides $1.9 trillion in relief funding to address the COVID-19 pandemic, support the US economy, and provide relief for impacted Americans, and includes provisions specifically affecting healthcare providers remaining on the frontlines.
Morgan Lewis has recently launched a new resource for our clients and friends, Questions on Vaccines, to help navigate as the US accelerates its goal of delivering safe and effective COVID-19 vaccines, employers, healthcare providers, and many others are considering the potential implications for their industries and organizations.
As coronavirus (COVID-19) cases begin to surge in Texas, Governor Greg Abbott issued Executive Order No. GA-27 on June 25 to preserve hospital bed availability for COVID-19 patients.
As we continue to look forward to a new post-pandemic reality, our NOW. NORMAL. NEXT. resource page has a number of recent publications that our friends of Health Law Scan may be interested in.
Morgan Lewis has recently launched a new resource for our clients and friends, Now. Normal. Next., to help navigate the world as we reemerge into a new post-pandemic reality. Health Law Scan will continue to monitor developments around the coronavirus (COVID-19) pandemic, and will begin to highlight our resources to help our healthcare clients navigate the myriad of challenges brought by this new reality.
As we all settle into our new sense of normalcy, Health Law Scan continues to monitor developments surrounding the coronavirus (COVID-19) pandemic. We have lawyers across the firm providing updates on a wide variety of topics to keep our clients apprised of all the developments.
Our telecommunications, media, and technology group prepared a LawFlash discussing two programs that the Federal Communications Commission established on March 31 to help eligible healthcare providers purchase and deploy telehealth technology. The programs provide immediate relief for telehealth and healthcare providers during the coronavirus (COVID-19) pandemic and aim to improve telehealth outcomes over the longer term.
The Center for Medicare and Medicaid Services (CMS) released a far-reaching interim final rule (IFR) to address the coronavirus (COVID-19) pandemic on March 30. The IFR represents a comprehensive set of policy changes designed to shift the provision of Medicare services from face-to-face care to remote care through telehealth, in order to mitigate the risks of exposure to COVID-19 for patients and healthcare providers. Above all else, the IFR prioritizes physically distancing patients from their care teams and other patients.