US FDA Query Management (IRs/DRLs/CRLs) - Overview
After the submission of the Abbreviated New Drug Application (ANDA), the USFDA may raise queries (Screening Deficiency/IRs/DRLs/CRL) to the ANDA holder for additional information/clarification on the content that has been included in the ANDA.
Response to the US FDA deficiency letters should be submitted on time with sufficient data and suitable scientific justifications to receive approval on the goal date for the ANDA.
Delay in response and inadequate response to the USFDA may warrant an additional round of deficiency letters and subsequently delay the approval and market entry. Hence, it is very important for the ANDA applicant to adequately respond to the USFDA queries.
Freyr, with strong expertise in generics registration activities, can provide support in the USFDA query management, along with the submission of a complete response, to the US FDA.
US FDA Query Management (IRs/DRLs/CRLs) - Expertise
- Thorough review of the deficiencies received from the USFDA against registered content
- Preparation of an action plan
- Preparation of response strategy and guidance to the applicant on the activities to be performed
- Assessment of additional data and/or inputs received from ANDA applicants and identifying the gaps
- Preparation of response package with scientific justifications and supporting documents
- Correspondence with FDA/guidance for extension request and negotiation on the strategy
