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Faster approvals of generics and biosimilars, along with other measures aimed at reducing prescription drug prices, will be ongoing FDA priorities in 2018. Read More
In this issue of Drug Industry Daily, we examine some of the FDA’s priorities for 2018 and what industry experts expect to happen. We already know the FDA’s priorities for 2018 will include ongoing efforts to reduce drug prices, speed approvals for generics, and increase patient engagement, according to FDA officials and expert observers. On the quality front, the agency will target data-integrity as part of its new ConOps initiative. The EMA, meanwhile, will be juggling its regulatory obligations with Brexit preparations and the transfer of its headquarters from London to Amsterdam. Read More
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The FDA released a draft guidance for the development of drugs that use nanomaterials, stating the importance of describing and analyzing nanomaterials and their attributes in a product’s finished form. Read More
Modified-release products containing paracetamol will be suspended from the market in the European Union, the European Medicines Agency announced. Read More