The New Drug Application (NDA) is an application submitted to the US FDA for approval of a new drug through the 505(b)(1) NDA and 505(b)(2) NDA Regulatory pathway. Most sponsors find NDA submission challenging as they must identify the right Regulatory pathway for their drug development case and define the right 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 requirements. Apparent knowledge of the guidance detailing the reasons for RTF of a New Drug Application and its review process will save the investment (agency fee) and an ample amount of time for sponsors during the NDA filing process.
Freyr assists the sponsors with end-to-end Regulatory support for their NDA submission process, starting from the pre-NDA meetings to submission of NDA annual reports, and the life cycle management of the product.
- 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 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 the scientific issues with the US FDA.
- Strategic support in identifying the optimal Regulatory pathway for NDA submission.
- Regulatory support for pre and post-submission interactions and follow up activities with the US FDA throughout the NDA approval program.
- NDA post-approval life cycle 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.
- Gap-analysis of developmental data/source data against NDA submission/NDA registration requirements, and guidance to sponsors on a risk mitigation plan for the identified Regulatory gaps.
- Regulatory response strategy, preparation, and on-time response submission to the US FDA queries/information requests.
- Compilation and technical review of 505(b)(1) NDA and 505(b)(2) NDA packages (including preparation of Module 1 documents and other NDA registration forms), publishing, and submission of application in the eCTD format via the FDA ESG.