Articles and Blogs

On October 7, 2021, five years after issuing initial draft guidance on its enforcement approach for hospitals and health system pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act (the “Act”), the U.S. Food and Drug Administration (“FDA”) released revised draft guidance (“Draft Guidance”) that provides increased flexibility to hospitals and health systems…Read More

On Monday, October 11, Texas Governor Greg Abbott issued Executive Order GA-40, requiring that employers provide exemption from any COVID-19 mandate for reason of personal conscience, religious belief or for medical reason, including prior recovery from COVID-19. These exemptions are broader than those required under Title VII of the Civil Rights Act (for sincerely held…Read More

The Department of Health and Human Services Health Resources and Services Administration (“HRSA”) released multiple key Provider Relief Fund (“PRF”) updates over the past four weeks, which include opening a new application for additional PRF funding. The new funding application process and other updates are discussed in more detail below. Practical Takeaways The applications for…Read More

On September 28, 2021, the Federal Trade Commission (“FTC”) announced changes to its merger review process designed to increase the rigor of the review and “streamline” (in the FTC’s words) the interactions between the merging parties and the FTC. The announced changes will expand the potential topics covered during investigations, while also standardizing the negotiation…Read More

On September 14, 2021, HHS issued a ninth amendment (the “Ninth Amendment”) to the Declaration for medical countermeasures against COVID-19 (the “Declaration”) under the Public Readiness and Emergency Preparedness Act (“PREP Act”). This Amendment expands the scope of authority for licensed pharmacists along with qualified pharmacy technicians and interns relative to FDA-approved COVID-19 therapeutics. More…Read More

For employers and workplaces that are operating entirely remotely, Department of Homeland Security (“DHS”) and U.S. Immigration and Customs Enforcement (“ICE”) have temporarily implemented a flexible solution to assist in complying with the requirements related to Form I-9 completion. The initial announcement on the flexibility in requirements related to Form I-9 completion was on March…Read More

Effective September 1, 2021, employers in Texas are subject to two significant amendments to the state employment law: SB 45 and HB 21 to the Texas Labor Code expand sexual harassment protections for employees in essentially all workplaces. More Employers Can Now Expect to Receive Legal Challenges Previously, only employers with 15 or more employees…Read More