Trump’s FDA choice Gottlieb offers solution to conflict-of-interest claims
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.
Heads up, pharma. Trump’s pushing GOP to put ‘competitive bidding’ on drugs in healthcare bill
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.
Trump Budget Proposes Steep Hike in FDA User Fees
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.
Adverse event reports rise rapidly even as Trump promises faster drug approvals
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.
Medical bodies slam Trump’s ‘devastating’ and ‘gutting’ research cuts
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.
Trump’s first budget seeks to slash $6B from NIH, raise 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.”
Trump picks industry favorite Gottlieb to run FDA
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.
MIT researchers create implant to deliver drugs to pancreatic tumors
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.
Proposed U.S. bill would require docs to report medical device adverse events to the FDA
A proposed bill from U.S. representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) would have quite an impact on doctors when it comes to reporting potentially serious problems with medical devices.
Trump signals elimination of ‘burdensome’ drug approval system
In a typically fiery speech, President Donald Trump in his first joint address to Congress last night tore into the FDA’s “slow and burdensome approval process,” and gave vague assurances that this would be “eliminated … so more lives could be saved.”