Request for Supplementary Information

A request for supplementary information is a formal communication made by a regulatory authority to a drug applicant or sponsor, requesting additional data, clarifications, or supporting documentation related to a submitted application. This request is typically made during the evaluation process when the regulatory authority requires further information to adequately assess the safety, efficacy, quality, or compliance aspects of the product.

The request for supplementary information is a normal part of the regulatory review process, and it aims to ensure that the regulatory authority has all the necessary data and documentation to make an informed decision about the product’s approval or authorization. It provides an opportunity for the applicant to address any gaps or deficiencies in the original application and to provide the requested information within a specified timeframe.

The supplementary information request usually includes specific questions or areas where the regulatory authority seeks clarification or additional data. The applicant is expected to respond to the request in a comprehensive and timely manner, providing the requested information in a clear and organized manner.