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In another attempt to quell the opioid abuse epidemic, two FDA advisory committees voted Wednesday to recommend approval of an NDA for an immediate-release opioid painkiller. Read More
FDA commissioner nominee Scott Gottlieb was grilled by a Senate panel Wednesday over his financial ties to the industry he would be charged with regulating. Read More
President Trump released a budget blueprint calling for FDA user fees to rise to more than $2 billion for fiscal 2018 — up from the $1.36 billion set for 2017 — and for $1 billion to fund the 21st Century Cures Act. Read More
The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing. Read More
The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Read More
Democrats grilled industry representatives on drug pricing Tuesday at a Senate health committee hearing on reauthorizing the FDA’s user fee programs. Read More