The Health Resources and Services Administration (HRSA) released its long-awaited 340B program omnibus guidance, often called the “Mega-Guidance” today. RWC-340B has reviewed the Mega-Guidance and is quite troubled by proposed changes…
August 18, 2015 marked the 25th anniversary of the passing of the Ryan White CARE Act, which marked a dramatic shift in the federal strategy for comprehensive treatment of HIV/AIDS. According…
On June 17, 2015, HRSA proposed regulations to implement elements of the Affordable Card Act that required the agency to develop guidelines for assessing civil monetary penalties on drug manufacturers…