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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
The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on measuring drug risks to human reproduction. Read More
The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. 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 ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. 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take a risk-based approach when assessing similarity of a reference product’s quality attributes, the FDA said in new draft guidance — pitched as part of the agency’s effort to lower drug prices.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
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
FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals. Read More