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In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
The FDA hopes to bolster its scientific staff in 2018 — not only to expedite product reviews, but to meet its commitments to industry under the user fee agreements — by implementing a pilot hiring program focused on addressing the approximately 15 percent of positions currently unfilled at CDER and CBER, which total about 1,000 vacancies. Read More
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