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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
When given the opportunity to use real-world data and adaptive trial designs to secure marketing authorization, drug sponsors often struggle to develop innovative approaches. Read More
The FDA is considering tightening up its requirements for OTC topical antiseptic products with a proposal that calls for a slew of new effectiveness and safety data. Read More