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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
The FDA does not intend to object to an institutional review board waiving informed consent requirements for certain clinical investigations considered to be “minimal risk,” according to a new agency guidance effective immediately. Read More
The agency plans to use the pilot to assess industry’s ability to meet the DSCSA’s requirements, including identifying illegitimate products and preventing diversion. Read More