Pharmaceutical drug development is generally complicated and expensive. I have no reason to believe this will ever change. In recent years, however, FDA makes an extra effort to help the industry to bring new promising treatments faster to the market. Despite that willingness to accelerate drug development, that is possible only in some cases, pharma and biotech still operate in a highly complex regulated environment, dealing with many issues that can surface out from the poorly predicted development and commercialization risks. Thus not all the drug candidates can and will reach the market. Continue reading →