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PhRMA’s CEO cited industry information silos and other barriers to sharing data, as well as clinical trial design issues, that could be modified to expedite the work. Read More
The FDA is looking to get involved with sponsors earlier in the development process for new drugs, and to further help speed the drugs to market through improving the design of clinical trials, Commissioner Scott Gottlieb said. Read More
Biosimilar sponsors should take a risk-based approach when assessing similarity of a reference product’s quality attributes, the FDA said in new draft guidance — pitched as part of the agency’s effort to lower drug prices. Read More
A review of legal databases was unable find any liability lawsuits against pharmaceutical companies related to four years’ worth of products used under expanded access, according to a study by FDA researchers. Read More
The European Medicines Agency updated two guidelines on clinical trials for cardiovascular treatments in acute coronary syndrome and chronic heart failure, first adopted in 2000. Both guidelines are scheduled to take effect March 1, 2018. Read More
The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Read More
The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More
More than a dozen pharmaceutical industry leaders agreed to work together to develop new painkillers without the harmful addictive effects of opioid medicines — and to use the NIH as a central clearinghouse for research to speed up product development. Read More