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HHS Secretary Sylvia Burwell announced a final rule Tuesday that would more than double the number of patients for whom physicians can prescribe opioid rescue drugs. Read More
The FDA is breaking down how drugmakers should comply with standards established by the International Council for Harmonization and the United States Pharmacopeia for controlling elemental impurities. Read More
Drugmakers developing treatments for uncomplicated vulvovaginal candidiasis should conduct two adequate and well-controlled clinical trials with a superiority design to demonstrate efficacy, the FDA recommends. Read More
The FDA is providing recommendations on clinical trial designs for sponsors developing antiviral drugs to prevent and treat recurrent herpes labialis, or herpes-related sores that form around the mouth. Read More
The FDA is proposing that drugmakers importing products into the U.S. submit additional product identification information to allow the agency to better focus on products that pose greater risks and to speed up “May Proceed” determinations. Read More