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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