New Drug Application Submission - Overview
New Drug Application (NDA) under the US FDA’s 505 b (1) and 505 b (2) pathway is the application process through which pharmaceutical medicinal products are approved for human use. An FDA NDA submission through the 505 b(1) Regulatory pathway should contain full reports of investigations on safety and effectiveness. Whereas, the 505(b)(2) FDA NDA submission Regulatory pathway is used for applications with a change in dosage form, change in strength, and change in the route of administration for the drugs that were evaluated and approved by the FDA as part of other NDAs.
For most of the sponsors, the challenge is to understand the FDA NDA submission regulations, identify the right Regulatory pathway for their drug development case, and define the right Regulatory strategy for the FDA NDA filing process. For an FDA NDA submission, all mandatory information required as per Federal Regulations must be submitted by the sponsor. In case the sponsor fails to submit adequate information, 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. Apparent knowledge of the guidance detailing the reasons for RTF of an NDA and its review process will save investment (agency fee) and an ample amount of time for sponsors during the FDA NDA filing process.
Freyr assists the sponsors with end-to-end Regulatory support for the FDA NDA filing process, starting from pre-NDA meetings to submission of NDA annual reports and further lifecycle management of the product.
New Drug Application Submission - Expertise
- Strategic support in identifying the optimal Regulatory pathway for an FDA NDA submission.
- Expert advice on availing agency support via expedited programs (i.e., Fast Track designation, Breakthrough Therapy designation, Accelerated Approval process, and Priority Review designation).
- Pre-submission meeting support, including briefing package preparation, and meeting representation to discuss scientific issues with the FDA NDA filing.
- Extensive understanding of Federal regulations and submission pathways (505(b)(1), 505(b)(2), and 505 (j)), data requirements for NDA preparation, and significant experience in the FDA NDA filing Process and NDA review process.
- Gap analysis of developmental data/source data against the NDA submission requirements and guidance to sponsors on a risk mitigation plan for the identified Regulatory gaps.
- Compilation and technical review of 505(b)(1) NDA and 505(b)(2) NDA packages (including preparation of Module 1 documents and other NDA application forms), publishing, and submission of application in the eCTD format via the FDA ESG.
- NDA templates with technical information for NDA preparation and eCTD submissions.
- Regulatory response strategy, preparation, and on-time response submission to USFDA queries/information requests.
- Regulatory support for pre- and post-submission interactions and follow-up activities with the FDA throughout the NDA approval program.
- NDA post-approval lifecycle management (supplements, CBE 30, CBE, annual reports, etc.).
- Strategy and submission support in managing Complete Response Letters (CRLs) for NDAs.
