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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
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
The House Oversight Committee has released two new staff reports from its ongoing drug pricing investigation that shed light on the tactics employed by Bristol Myers Squibb, Celgene and Teva Pharmaceuticals to raise the prices of two blockbuster drugs and turn massive profits, the same day committee Democrats grilled the company’s CEOs at its drug pricing hearing. Read More
Former FDA Commissioner Mark McClellan says it’s possible that a COVID-19 vaccine will be available for some portions of the population before year’s end but that it was never realistic to expect one before the Nov. 3 presidential election. Read More
Canadian Prime Minister Justin Trudeau said he is willing to consider U.S. plans for importing prescription drugs from Canada but that the needs of his own country come first. Read More
The House of Representatives yesterday passed a bipartisan bill in a voice vote to extend the FDA’s rare pediatric drug priority review voucher program by four years. Read More
The FDA has issued Aquestive Therapeutics a complete response letter (CRL) for its Libervant (diazepam buccal film) for the management of seizure clusters. Read More
The FDA’s safety program designed to reduce opioid abuse and misuse is not well suited to tackling the continuing epidemic in the U.S., mainly due to a lack of cooperation from makers of opioids, the HHS Office of the Inspector General (OIG) says is a new report. Read More