New Drug Application (NDA) is an application submitted to the US FDA for approval of a new drug through 505(b)(1) NDA and 505(b)(2) NDA Regulatory pathway. Most sponsors find it challenging to identify the right Regulatory pathway for their drug development case and defining the right Regulatory strategy for NDA filing process. Moreover, if the information submitted by sponsor 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 ample amount of time to sponsors during the NDA filing process.
Freyr assists the sponsors with end-to-end Regulatory support for the NDA process, starting from pre-NDA meetings to submission of NDA annual reports and further 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 on 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 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 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 eCTD format via the FDA ESG