We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A proposed HHS rule that would restructure the drug rebate system to send discounts straight to consumers has reached the Office of Management and Budget for a final review in just a few months, a Senate committee heard Wednesday. Read More
Generic drug makers are pushing back against a new Senate bill over concerns that proposals to revise patent arbitrage will deter generics from reaching the market. Read More
CDER Director Janet Woodcock flagged proposals in the FDA’s fiscal year 2020 budget designed to encourage drug competition and seal regulatory loopholes in testimony before a Senate drug pricing hearing on Wednesday. Read More
“Hospitals are the frontline of patient safety and safely compounded drugs are necessary for effective patient care,” the Inspector General said. Read More
Many questions can only be resolved with high quality real-world data, said Sean Mackey, chief of Stanford University’s Division of Pain Medicine. Read More
The FDA announced on Tuesday that it will add new information to its patent database, in a move the agency hopes will bring more sunlight into the ANDA approval process. Read More
Nearly three-fifths of European Medicines Agency workers displaced by the ongoing Brexit preparations have made it across the English Channel to temporary headquarters, the agency said. Read More
Acting FDA Commissioner Ned Sharpless says he’d be glad to become the agency’s official boss but even if it’s not him, it’s important to get a permanent commissioner in there soon. Read More