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In late September, the Food and Drug Administration (FDA) released a draft guidance on benefit-risk assessments for drugs and biological products. The draft guidance includes considerations the agency uses when weighing the...more