On September 10, 2021, the Acting Commissioner of Food and Drugs, Janet Woodcock, M.D., and Director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., PhD., issued a statement on behalf of the FDA regarding the
Health Law Pulse
Leading insight on legal developments in the healthcare and life sciences industries.
Health Law Pulse, published by Norton Rose Fulbright, focuses on legal developments and regulatory issues in the healthcare sector. The blog covers topics such as healthcare compliance, value-based care, chronic care management, healthcare regulations, sanctions and export controls, and the impact of technology on healthcare law. It also addresses broader themes like healthcare litigation, policy changes, and the intersection of healthcare with financial and corporate law. The content is aimed at legal professionals and stakeholders interested in the evolving legal landscape affecting healthcare providers, payers, and related entities.
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COVID-19 Update: Biden Administration requires COVID-19 vaccine or proof of negative COVID-19 test for employees at large companies
On September 9, 2021, President Biden announced a new, upcoming mandate that requires all employers with 100 or more employees “to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result…
COVID-19 update: United States military requires COVID-19 vaccine
Secretary of Defense Lloyd J. Austin III issued a memorandum on August 25, 2021, mandating immediate and full COVID-19 vaccines for all members of the United States Armed Forces, including the Ready Reserve and National Guard. The memorandum began, “To…
COVID-19 Update: Pfizer vaccine fully approved by FDA
On August 23, 2021, the US Food and Drug Administration (“FDA”) granted full approval for the Pfizer-BioNTech COVID-19 (“Pfizer”) vaccine for individuals sixteen-years-old and older. This change shifts the vaccine from emergency-use only and is the first COVID-19 vaccine granted…
COVID-19 update: White House recommends COVID-19 booster shot for most Americans
On August 18, 2021, the Biden Administration announced with top US health officials a recommendation that Americans receive a COVID-19 booster shot eight months after their second dose was administered. The Administration is not recommending a booster for the one-dose…
COVID-19 Update: FDA announces availability of COVID-19 booster shot for immunocompromised
On August 12, 2021, the United States Food and Drug Administration (“FDA”) authorized a COVID-19 vaccine booster for immunocompromised individuals. Because booster vaccines were not previously authorized under the FDA’s emergency use authorization, the FDA’s announcement today was a necessary…
World Health Organization urges moratorium for COVID-19 booster shots
On August 4, 2021, Director-General Tedros Adhanom Ghebreyesus of the World Health Organization (“WHO”) emphasized the import of delaying the administration of booster shots for the COVID-19 vaccine until at least September 2021. He believes this delay will allow at…
Biden administration requires federal employees to receive COVID-19 vaccination with Delta variant on the rise
On Thursday, July 29, 2021, the White House confirmed that the Biden Administration would articulate new goals related to COVID-19 and the Delta variant:
- Strengthening safety protocols for federal employees and federal contractors.
- Protecting those who serve our country.
- Expanding
…
COVID-19 update: CDC releases updated masking recommendations
On July 27, 2021, Dr. Rochelle Walenksy updated the United States Centers for Disease Control and Prevention’s (“CDC”) recommendation regarding mask use for vaccinated individuals in a Media Telebriefing concerning COVID-19. At the time of this writing, the transcript is…
CMS issues 2022 OPPS proposed rule
On Monday, July 19, 2021, the Centers for Medicare & Medicaid Services (“CMS”) released its Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgery Center (“ASC”) proposed rule for Calendar Year (“CY”) 2022. In the proposed rule, CMS proposes a…