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.
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.
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.”
The FDA has unveiled new draft guidance for 3-D printing, laying out its thoughts on the technology and device regulation as more med tech companies jump into the fast-growing field.
The medical device industry should not treat cybersecurity as though it were a check box—and they may want to brush up on FDA’s role, says Seth Carmody, PhD, cybersecurity program manager at FDA.
The U.S. Food and Drug Administration announced in September 2016 it has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors. These actions come about a month after the FDA began enforcing new federal regulations making it illegal nationwide to sell e-cigarettes, cigars, hookah tobacco, and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check photo ID of anyone under age 27, among other restrictions.
Glaucoma can be treated with daily eye drops, but their fiddly nature can affect patient adherence. A team from Massachusetts has developed a drug-delivering contact lens that is at least as effective as daily eye drops in animal models.
While sleep disturbance has long been considered a symptom of post-traumatic stress disorder (PTSD), recent studies show it may also contribute to the condition. Brain State Technologies presented data in August 2016 suggesting a wearable device for sleep optimization could decrease the risk of PTSD.