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Opioid sponsors would have to prove that their drug candidates are better than currently approved drugs under new guidelines that the FDA is considering, the agency announced Thursday. Read More
Sanofi is getting into Big Data in a big way, teaming up with Internet giant Google on a real-world database that both companies hope will “radically transform” the way drugs are developed and delivered. Read More
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