Responding to “enhanced understanding in this area” and “comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos,” the U.S. Food and Drug Administration recently issued a final rule amending regulations “regarding donor …

FDA Amends Regulations Concerning Embryo Donation Read more »

The U.S. Centers for Medicare and Medicaid has issued a proposed rule (81 Fed. Reg. 39448, 6/16/16) to modernize and revise requirements hospitals and critical access hospitals (CAHs) must meet to participate in Medicare and Medicaid.  [See “Conditions of Participation” …

CMS Issues Proposed Rule Updating Conditions of Participation Read more »

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to RXQ Compounding LLC in Athens Ohio, finding deficiencies in how the outsourcing facility was producing drugs.  Outsourcing facilities* must comply with Federal Food, Drug, and Cosmetic Act …

FDA Warning Letter Sent to Ohio-Based Compounding Pharmacy Read more »

The Equal Employment Opportunity Commission (EEOC) recently issued two rules on “how Title I of the Americans with Disabilities Act (ADA, Pub. Law 101-336, 7/26/90) and Title II of the Genetic Information Nondiscrimination Act (GINA, Pub. L. 110-233, 5/21/08) apply …

EEOC Issues Rules on Employer Wellness Plan Incentives Read more »