In more recent years, the FDA has become increasingly responsible for advancing the public health by working within legislated time-frames to speed the review of new drug products that have the potential to meet highly unmet medical needs. Additionally, the agency has streamlined some regulations with the intent of reducing the cost of drug development and hastening the introduction of generic products. In the 1980s and 1990s, the FDA came under significant criticism by both the public and the pharmaceutical industry for not acting quickly enough to make drugs for unmet medical needs available to patients who were in need of them. Comparisons were made to countries outside the United States, where often new and innovative drugs and biologics were commercially available years before they were available in the United States. During the same time period, the AIDS crisis in health care occurred with the urgent need for new products for this devastating disease. As a result of the public pressure, legislation was passed that made it necessary for FDA to work more quickly and interact with the industry more frequently, to facilitate the development, review, and approval of innovative drugs. As a result, U.S. citizens are now often among the first in the world to have access to drugs and biologics for unmet medical needs.
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What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.