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Despite FDA’s increased efforts to prevent new drug shortages, a large number of drug shortages remain an ongoing problem, a congressional watchdog contends. Read More
Sandoz’s biosimilar of Amgen’s Enbrel has received a recommendation of approval from an FDA advisory committee, making it the second biosimilar to earn recommendation within a 24-hour period.
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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
Brexit is unlikely to spur monumental changes for the life science industry, but regulatory compliance experts do acknowledge the possibility of many headaches. Read More
Randomized controlled trials have long been the standard for efficacy claims, but a new report calls on the FDA to lay out terms for using real-world data in the drug approval process. Read More
As the life science industry waits for Brexit to be formalized, regulatory compliance experts foresee a standstill in the country’s research and development. Read More
An FDA advisory committee recommended the approval of Merck’s bezlotoxumab to prevent Clostridium difficile infection recurrence in patients 18 and older. Read More
The FDA is providing recommendations on clinical trial designs for sponsors developing antiviral drugs to prevent and treat herpes-related sores that form around the mouth. 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 says. Read More