What is the standard deadline for a New Drug Application (NDA)?

The standard deadline for a New Drug Application (NDA) is 10 months. This timeline is established by the Food and Drug Administration (FDA) as part of their review process for new drug submissions. The 10-month period applies to a standard review and allows the FDA to thoroughly examine the safety and efficacy data of the new drug, as well as ensure compliance with applicable regulations. This timeline can vary if the application qualifies for priority review, which may shorten the review period to six months, but for standard applications, 10 months is the expected timeframe. This standard review period encourages the timely evaluation of potentially important new drugs while maintaining the necessary rigor of the approval process.