As the Biden administration moves ahead to implement provisions of the Inflation Reduction Act (IRA), including those related to drug negotiation and inflationary rebate, the administration announced three Medicare and...more
In late December, Congress passed and President Biden signed into law a $1.7 trillion year-end omnibus spending bill to fund the federal government through FY2023. This alert summarizes the notable health policies and...more
With President Biden signing the Inflation Reduction Act (IRA) into law on August 16, the next big question is what the last third of 2022 will bring. Enacting the IRA takes the “will it or won’t it happen” issue of...more
Nearly five months after releasing their initial 21st Century Cures 2.0 draft, Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) introduced the long-anticipated bill on November 15. The bill includes...more
In late September, the Food and Drug Administration (FDA) released a draft guidance on benefit-risk assessments for drugs and biological products. The draft guidance includes considerations the agency uses when weighing the...more
On June 9, 2021, Arnold Ventures, researchers from the Boston University School of Public Health and Faegre Drinker hosted a virtual event to explore the issue of fraud in substance use disorder (SUD) treatment. In response...more
On November 7, the U.S. Food and Drug Administration (FDA) announced the launch of the MyStudies app, the latest in a series of concrete activities to drive the integration of the patient voice in clinical trials and the drug...more
On January 11, 2018, the Food and Drug Administration (FDA) released its 2018 Strategic Policy Roadmap, which sheds light on the agency’s key focus areas for the year. This Roadmap builds on some of the FDA’s existing work,...more
Earlier this month, the Food and Drug Administration (FDA) solicited public comments on the agency’s proposal to create a new Office of Patient Affairs. The agency said in its Federal Register notice that the concept was...more