Some FDA initiatives for improving the process of drug development and approval in the United States.
1) Accelerated approval
The accelerated approval program run by FDA allows sponsors to request approval on the basis of alternate findings. Also called surrogate endpoints, these are indirect assessments of disease status, for example, a change in lab results or improvements in symptoms related to the disease. These endpoints can also be used to assess the effectiveness of the treatment or therapy. With accelerated approval programs, the approval process for drugs meant for life-threatening diseases can be expedited in order to provide for an unmet medical need.
2) Engaging drug sponsors early in the drug development process
By interacting with drug sponsors in the early stages of the drug development process, the FDA is trying to reduce the time spent on the development of new drugs. With this effort, the FDA seeks to speed up the development, review and marketing of new treatment options. The FDA conducts meetings with the drug sponsor on a regular basis in order to ensure that an agreement is reached on the ideal design of clinical research and the resulting data is reviewed in a timely manner.