We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In recent years, the FDA has tended to approve new opioid drugs “on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations of patients who could tolerate the drug,” according to a new study led by researchers at the Johns Hopkins School of Public Health. Read More
Sponsors of opioid use disorder (OUD) treatments should expand their trials beyond collecting evidence for an NDA submission and gather data on additional clinically meaningful outcomes the FDA considers “highly valuable,” according to a final guidance the agency released last week. Read More
President Trump has signed a short-term funding bill that keeps the government up and running through Dec. 11. The continuing resolution does not contain any new FDA funding and means the agency will operate using fiscal 2020 funding levels through that date. Read More
Former FDA Commissioner Scott Gottlieb strongly defended the agency’s approach to getting a vaccine out to the public in the shortest amount of time, criticizing the Trump administration’s apparent attempt to derail a planned guidance the president believes could reduce the chance of having a proven vaccine before the November election. Read More
Responding to charges that the justifications for dramatic drug price increases to fuel expenses are “baseless,” the heads of Amgen, Mallinckrodt and Novartis told lawmakers Thursday they are willing to pull back in some instances on continuing steep price hikes. Read More
Two leading COVID-19 vaccine developers, AstraZeneca and Moderna, have hit new speed bumps that could delay their promising COVID-19 vaccine candidates, reducing the possibility of a vaccine being ready ahead of the U.S. presidential election on Nov. 3. Read More
Individuals over the age of 65 are likely to be excluded from more than 50 percent of trials studying COVID-19 therapies and 100 percent of COVID-19 vaccine trials, despite the fact that these older patients account for more than 80 percent of deaths related to the disease, according to a new study in JAMA Internal Medicine. Read More