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The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current thinking on extrapolating data in pediatrics. Read More
The European Medicines Agency launched a new plan to streamline procedures for developing advanced gene and cell therapies, including adapting manufacturing requirements to products’ specific challenges. Read More
The FDA published new product-specific draft guidances for 30 active ingredients — including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives — outlining the agency’s preferred methods for supporting ANDA submissions. Read More
The European Medicines Agency is considering a draft addendum developed by the International Conference on Harmonization for the ICH’s 1998 clinical trial statistics guideline. Read More
The FDA is looking to improve the design of clinical trials and it plans to get involved with sponsors earlier in the development process for new drugs, and to help speed the drugs to market, Commissioner Scott Gottlieb said. Read More
Three quarters of clinical trial managers still report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases, according to new research from the Tufts Center for the Study of Drug Development and Veeva Systems. Read More
The European Medicines Agency outlined its thoughts on the use of evidence generated through extrapolation techniques in regulatory assessments, in a draft reflection paper. Read More
A new Cancer Moonshot collaboration of NIH with 11 biopharmaceutical companies will undertake to identify and validate biomarkers to advance immunotherapies as its first order of business, the agency announced. 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