On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The need for the guidance stemmed from the 2018 Farm
On Jan. 3, the Food and Drug Administration (FDA) finalized a rule allowing more retail pharmacies to dispense abortion pills upon completion of a certification process. The FDA finalized the changes after reviewing supplemental applications from manufacturers of the drug
The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B program prohibits pharmaceutical manufacturers from imposing
Former co-owner of the now defunct New England Compounding Center (NECC) Gregory Conigliaro may face prison time for conspiring to defraud the U.S. Food and Drug Administration (FDA). Prosecutors argued Conigliaro conspired with more than a dozen others at NECC
On Nov. 15, the Superior Court of Fulton County issued an order finding that two sections of the Georgia LIFE Act (the Act) – Sections 4 and 11 – were void ab initio. Section 4 of the Act criminalized abortions
The United States Court of Appeals for the Fourth Circuit decision in US ex rel. Sheldon v. Allergan Sales, LLC, a qui tam False Claims Act (FCA) suit, affirms the complexity of pricing and Medicaid rebates under the Medicaid Drug Rebate
On Aug. 24, the United States District Court for the District of Idaho issued a preliminary injunction blocking the enforcement of Idaho’s new abortion law. The law was set to take effect on Aug. 25, 2022. As previously reported,
On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the Affordable Care Act (ACA). The aim of
On Aug. 2, the U.S. Department of Justice (DOJ) filed suit against the state of Idaho to block a state abortion law set to take effect on Aug. 25, claiming that it violates the federal Emergency Medical Treatment and Labor
To coincide with the 32nd anniversary of the Americans with Disabilities Act (ADA), the Department of Health and Human Services Office for Civil Rights (OCR) and the Department of Justice’s Civil Rights Division (CRT) jointly issued Guidance on Nondiscrimination in