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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
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 revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. Read More
The FDA finalized 48 guidances for generics manufacturers, outlining the recommended studies for demonstrating bioequivalence for dozens of active ingredients and combinations, to assist the industry with generating evidence to support ANDA approvals. Read More
The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. Read More