H.R. 2430 of the FDA Reauthorization Act (FDARA) has been signed into law. This bill extends the Federal Food, Drug, and Cosmetic Act through FY2022 and revises and renews four user fee agreements between industry and FDA for new drug applications. PBOA president Gil Roth said, “A year ago, industry ratified the second iteration of Generic Drug User Fee Amendments (GDUFA II), and today I commend the White House for signing it into law via FDARA. GDUFA II will empower FDA and industry to work ...