Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday, April 4, 2017 that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts.
The US Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA), which carries out the agency’s inspection program, will officially begin a major overhaul in the coming weeks, according to FDA’s Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.
Scott Gottlieb’s close links to the pharma industry have threatened to undermine his chances of becoming FDA commissioner—but he thinks he has a solution.
How would a “competitive bidding process” for drugs work? We may soon find out, if President Donald Trump gets his way with the Republican healthcare bill.
President Trump released his first budget blueprint last week, 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.
Even as the new administration is promising to sweep away some FDA practices to speed drugs to market, a new study has found that there has been a dramatic rise in the number of drug side effects reported in recent years.
President Donald Trump’s first budget has not gone down well with the medical research and regulatory communities, which have come out against his plans to cut nearly $6 billion from the NIH and possibly double FDA user fees.
President Donald Trump’s first budget will take $5.8 billion away from the National Institutes of Health (NIH), around 20% of its total, with FDA user fees also set to rise as biopharmas should “pay for their share.”
President Donald Trump has chosen Scott Gottlieb to run the FDA. Gottlieb has a history of calling for faster approvals, greater regulatory transparency and a realignment of the balance of power between FDA and doctors, but as an industry insider is seen as a safer pair of hands than some of the other mooted candidates.
Pancreatic cancer is usually treated with intravenous chemotherapy, but these injections often fail because the pancreas lies so deep within the abdomen. Now researchers from MIT and Massachusetts General Hospital have developed a minimally invasive implantable device that delivers chemo drugs directly to pancreatic tumors.