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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
The Reagan-Udall Foundation unveiled an online directory of dozens of pharmaceutical company policies on expanded access to investigational therapies. Read More
The FDA issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions. Read More