Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could ...
FDA simplifies rules governing use of popular acne medication isotretinoin
The iPLEDGE program is a risk management system mandated by the U.S. Food and Drug Administration to prevent fetal exposure to isotretinoin, a medication used for severe acne that doesn’t respond to ...
$1.6 Billion Awarded: Lawyers Build Record-Setting Case Against Janssen
Relators made their showing—that Janssen Products' off-label marketing plan was nationwide in scope—by presenting a multitude ...
Fierce Pharma18h
For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty
The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...