Ricki A. Chase, M.S, Lachman Consultants, wrote a recent article for Contract Pharma looking at the benefits and challenges of the trend towards combination products.
Here is a brief excerpt from the article: “As the life sciences industries have continued to evolve, the need for ever changing nomenclature has evolved along with it. It was once easy to understand the discussion amongst a group of industry and government professionals when referring to the “pharma” business. And by the late 1990s, after the implementation of the Quality System Regulation (QSR) (see 21 CFR Part 820), those in the device business had begun to adapt to the new language of design control requirements. Technology has developed in ways once unthought of, including the development of biosimilar drug products and complex cell and gene therapies.”