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The FDA’s use of real-world evidence in regulatory decision-making and further implementation of the 21st Century Cures Act are the biggest trends in clinical trials to track in 2018, according to the agency and industry experts. Read More
Quality experts and FDA officials predict 2018 will bring more streamlined FDA inspections and a greater focus on digital records and data integrity, as the agency implements its ambitious Concept of Operations initiative announced earlier this year. Read More
The FDA is revising its 20-year-old guidance on the appropriate categorization of changes in chemistry, manufacturing and controls information in approved BLAs, based on a tiered reporting system. Read More
The PTO’s Patent Trials and Appeals Board launched an inter partes review of two patents for Sanofi’s Lantus insulin glargine injection following a challenge from Mylan. Read More