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In late September, the Food and Drug Administration (FDA) released a draft guidance on benefit-risk assessments for drugs and biological products. The draft guidance includes considerations the agency uses when weighing the...more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 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