Types of regulatory queries in the context of US FDA regulation

Types of regulatory queries in the context of US FDA regulations, along with an explanation of each:

Here are the enlisted regulatory queries received for US FDA application for Drug

1. Information Request (IR): This is when the FDA asks for more data, clarification, or additional documentation related to a submitted application. It helps ensure that the information provided is complete and accurate.

2. Deficiency Letter (DL): Also known as a Complete Response Letter (CRL), this is a communication that outlines any deficiencies or issues identified by the FDA during their review of an application. The applicant needs to address these concerns before the application can move forward.

3. Clarification Request (CR): If the FDA needs more clarity on certain aspects of the submission, they may send a Clarification Request. This helps resolve any uncertainties or ambiguities in the provided information.

4. Request for Additional Information (RAI): This type of query asks for more data or explanations to support the application. It’s a way for the FDA to gather additional details that might be needed for their assessment.

5. Request for Comment (RFC): If there are specific matters the FDA wants to discuss or seek input on, they may issue a Request for Comment. This helps involve the FDA’s expertise in relevant discussions.

6. Meeting Request: Applicants can formally request a meeting with the FDA to discuss particular issues, questions, or concerns. This facilitates direct communication and can help resolve issues more effectively.

7. Discipline Review Letter (DRL): The FDA provides feedback on a specific discipline or area within the regulatory submission, such as chemistry, manufacturing, or clinical aspects. The DRL highlights the FDA’s assessment and any adjustments required in that specific area.

Each type of query serves a purpose in ensuring the quality, completeness, and accuracy of regulatory submissions, and they play a crucial role in the FDA’s review process. The timeframe for these queries varies based on factors such as the complexity of the submission and the FDA’s workload.

In summary of Types of regulatory queries in the context of US FDA regulation:

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