New Drug Applications - Overview
The New Drug Application (NDA) is submitted to the United States Food and Drug Administration (US FDA) for approval of a new drug through the 505(b)(1) and 505(b)(2) NDA Regulatory pathways. Most sponsors find NDA submissions challenging as they must identify the right pathways for their drug development case and define the appropriate Regulatory strategy for the NDA filing process. Moreover, if the information in the NDA submission is inadequate, the US FDA may Refuse-to-File (RTF) the NDA, due to which the sponsor cannot move forward unless additional information is submitted to comply with the Agency’s requirements. Knowledge of the guidance detailing the reasons for an RTF of a new drug application and its review process will save the investment (agency fee) and time for sponsors during the NDA filing process.
Freyr assists sponsors with end-to-end Regulatory support for their NDA submission process, starting from the pre-NDA meetings to the submission of NDA annual reports and lifecycle management of the product.
New Drug Applications - Expertise
- Expert advice on availing agency support via expedited programs (i.e., Fast Track designation, Breakthrough Therapy designation, Accelerated Approval process, and Priority Review designation).
- Extensive understanding of the Federal regulations and submission pathways (505(b)(1), 505(b)(2) and 505 (j)), data requirements for New Drug Application (NDA) preparation, and significant experience in NDA filings and NDA review process.
- Pre-submission meeting support, including briefing, package preparation, and meeting representation to discuss scientific issues with the US FDA.
- Strategic support in identifying the optimal Regulatory pathway for the NDA submission.
- Regulatory support for pre- and post-submission interactions and follow-up activities with the US FDA throughout the NDA approval program.
- Post-approval NDA lifecycle management (Supplements, CBE 30, CBE, Annual Reports, etc.).
- Strategy and submission support in managing Complete Response Letters (CRLs) for NDA registration.
- NDA templates, with technical information for NDA preparation and eCTD submissions.
- Regulatory response strategy, preparation, and on-time response submission to the US FDA queries/information requests.
- Gap analysis of developmental data/source data against NDA submission/NDA registration requirements and offering guidance to sponsors for designing a risk mitigation plan for the identified Regulatory gaps.
- Compilation and technical review of 505(b)(1) and 505(b)(2) NDA packages (including preparation of Module 1 documents and other NDA registration forms), publishing, and submission of the application in the eCTD format via the FDA ESG.
