Blog Post | Q4 2024 U.S. FDA Updates, Most Important Takeaways
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Q4 2024 U.S. FDA Updates, Most Important Takeaways

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Here’s an overview of key updates and programs shaping FDA’s direction in Q4 2024.

Here’s an overview of key updates and programs shaping FDA’s direction in Q4 2024.

Remote Regulatory Assessments (RRAs): Streamlining Oversight

The FDA has embraced both mandatory and voluntary Remote Regulatory Assessments (RRAs) as tools to enhance transparency and consistency in monitoring regulated industries. Updated in January 2024, the FDA’s guidance answers key questions, such as:

  • What qualifies as an RRA and how is it different from inspections?

  • What to expect when participating in an RRA?

  • Technological requirements for compliance.

With RRAs, establishments gain the opportunity to demonstrate compliance remotely, while the FDA ensures public health protection without disrupting operations. However, declining participation may have consequences, making early preparation essential.

Discontinuance and Manufacturing Interruption Reporting

Under Section 506C of the FD&C Act, the FDA mandates notifications for:

  1. Permanent discontinuation or interruptions in manufacturing finished products.

  2. Disruptions in the production of Active Pharmaceutical Ingredients (APIs) likely to affect supply.

Revised guidance released in February 2024 outlines:

  • Who must notify

    Entities involved in manufacturing critical drug products or APIs.

  • When to notify

    Early identification of potential disruptions.

  • Information to include

    Comprehensive details to aid FDA’s response. Failure to notify carries significant consequences, emphasizing the need for timely compliance.

Quality Metrics and the Quality Management Maturity (QMM) Program

The FDA's ongoing pursuit of manufacturing excellence includes its Quality Metrics and Quality Management Maturity initiatives. Since 2015, the FDA has aimed to standardize industry metrics to measure compliance and supply chain robustness. However, debates around standardization have persisted.

What’s New?

In 2024, the FDA has been piloting a QMM prototype assessment program:

  • Focus on fostering a culture of continuous improvement.

  • Recognize establishments with advanced quality practices.

  • Provide actionable insights for those striving to enhance quality management systems.

Metrics such as Manufacturing Process Performance, Laboratory Performance, and Supply Chain Robustness remain central. These metrics, when effectively measured, provide manufacturers with tools to reduce risks and maintain a reliable product supply.