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Merck urged the FDA to look into potential safety concerns as the agency seeks to widen patient eligibility criteria for oncology drug trials of HIV, hepatitis B and hepatitis C patients. Read More
Acting FDA Commissioner Ned Sharpless said the agency is inching closer to bringing cheaper insulins to the market but that critical regulatory questions remain. Read More
The guidance draws a line between information about patients’ health status or healthcare delivery “routinely collected from a variety of sources” and clinical evidence for a drug from analysis of real-world data. Read More
The acquisition is intended to shift the company from a traditional physician outreach model to a real-time approach that takes care of patient identification at the lab. Read More
The FDA issued a warning to GoLean Detox US of Charlotte, North Carolina for marketing unapproved, misbranded and potentially dangerous drugs. Read More
The FDA is willing to hold private meetings with sponsors of over-the-counter creams, gels and other topical medicines in order to protect trade secrets—but sponsors should understand that the meetings will eventually see the light of day, the agency says. Read More
Former FDA Commissioner Scott Gottlieb entered to applause at a D.C. press luncheon Friday, where he reflected on his leadership of the agency and stressed the importance of removing impediments to drug access by overhauling Medicare Part B. Read More