- Does FDA have a fast-track application process for NDAs or is it a strict 6-month to 10-month process?
- There is a rolling review program for fast-track applications. If agreed upon in advance, the company may submit completed sections of its NDA/BLA for review before they submit the entire application. FDA will start on sections of the NDA before the 6-month time log starts. Some products that treat severe life-threatening illnesses or unmet medical needs have been approved in less than 4 months.
- With FDA's concept of Equal Voice, do all the reviewers have to reach a consensus?
Equal Voice is an operational philosophy and set of practices to ensure that each professional viewpoint has been fully expressed, understood and brought into the decision-making process. When there is disagreement among members of a review team, each discipline must voice its concerns. This process engages the entire team in scientific debate and brings each viewpoint into discussion so that a decision can be made at the team level. The practice of Equal Voice does not mean that everyone necessarily agrees with the decision, but it ensures that all scientific and regulatory experts have input before a decision is made.
Submit additional questions via e-mail to: druginfo@fda.hhs.gov
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Topic: page 4 of 4 (Lesson: page 31 of 32)