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FDA Commissioner Scott Gottlieb updated lawmakers Thursday on the agency’s plan to help lower drug prices using its “untapped authority” to increase competition and streamline generic drug approvals. Read More
A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse. Read More
FDA Commissioner Scott Gottlieb sought to assure agency staff this week that Congress will reauthorize its user fee programs before the Sept. 30 deadline, which promise to provide the agency more than $1.4 billion in funding for reviewing activities and staff salaries in the next fiscal year. Read More
The European Medicines Agency revised its guideline on first-in-human clinical trials, highlighting the sponsor’s responsibility for mitigating risks to volunteers.in the study design. Read More
Missouri Gov. Eric Greitens (R) directed his health department to begin building a state prescription drug monitoring program to track prescribing and dispensing of several controlled drugs, including opioids. Read More
In the first trial verdict of thousands of similar suits, a federal jury ordered AbbVie to pay $150 million to a man who claimed the company’s testosterone drug AndroGel caused his heart attack. Read More
With just over two months left in the program, the FDA finalized a question-and-answer guidance for GDUFA I, covering ANDA reviews, inspections and self-identification of facilities. Read More
Some applicants surveyed said they were uncertain about the PRIME designation’s value, and felt it might limit their flexibility with other European regulators. Read More