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What is the typical review cycle duration for FDA registration in the United States?
Category：行業(yè)資訊 Date：2024-08-20 16:48:49 Author: Source:
Overall, while the FDA strives to meet these timelines, the actual review cycle can be affected by various factors and may vary for different types of products and submissions.

The typical review cycle duration for FDA registration in the United States can vary significantly depending on the type of product and the complexity of the submission. Here’s an overview of the general timelines:7(3).jpg

1. Medical Devices

  • 510(k) Notification: The FDA aims to review most 510(k) submissions within 90 days. However, the actual review time can be longer if the FDA requests additional information or if the submission is more complex.

  • Premarket Approval (PMA): For Class III devices, the PMA process generally takes about 180 days, but it can extend up to a year or more, depending on the complexity of the device and the completeness of the application.

2. Drugs

  • New Drug Application (NDA): The FDA has a standard review goal of 10 months from the filing date for new drug applications. For priority reviews, this period is reduced to 6 months. The actual review time may be longer if the FDA requires additional data or if there are significant issues with the application.

  • Abbreviated New Drug Application (ANDA): For generic drugs, the review process typically takes about 10 months, although it can be longer based on the specifics of the application and the workload of the FDA.

3. Biologics

  • Biologics License Application (BLA): The standard review time for BLAs is about 10 months, similar to NDAs. Priority reviews can be completed in 6 months, but again, the timeline can be extended if additional information is required.

4. Food and Dietary Supplements

  • Food Facility Registration: This process is generally quick, often completed within a few days to a few weeks.

  • Dietary Supplement New Ingredient Notification: Review times for these notifications can vary but are generally completed within 75 days.

Factors Affecting Review Time

  • Completeness of the Application: Incomplete or incorrect submissions can lead to delays as the FDA may request additional information.

  • Complexity of the Product: More complex products may require longer review times due to the need for additional data and more extensive evaluation.

  • FDA Workload: The FDA's current workload and resources can impact review times, with high volumes of applications potentially causing delays.

Overall, while the FDA strives to meet these timelines, the actual review cycle can be affected by various factors and may vary for different types of products and submissions.

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