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The FDA is recommending that companies conducting clinical trials on bacterial vaginosis drugs exclude patients with herpes simplex or human papilloma virus, one of dozens of recommendations the agency made on the subject Thursday. Read More
A measure to incentivize the development of abuse-deterrent opioids skated through the Senate on Wednesday, with its next stop being the White House. Read More
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