NDA 505 b (1) and 505 b (2)

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Overview

Overview

New Drug Application (NDA) is the application process through which pharmaceutical drugs for human use are approved by the United States Food and Drug Administration (US FDA). As per the legislation laid down in the US Federal Food, Drug, and Cosmetic Act, Regulatory pathways to approve new drugs are the 505(b)(1) NDA pathway and 505(b)(2) NDA pathway. The 505(b)(1) NDA pathway is used to obtain approval for new drugs with previously unapproved active components. An NDA application through this pathway should contain full reports of investigations on safety and effectiveness. The 505(b)(2) NDA pathway is another Regulatory route, and applications through this pathway should contain full reports of investigations of safety and effectiveness, but, where at least some of the information required for approval comes from studies not conducted by the applicant and for which the applicant has not obtained a right of reference. Also, the 505(b)(2) NDA route is used for the 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 challenging part would be understanding the FDA regulations, identifying the right Regulatory pathway for their drug development case, and defining the right Regulatory strategy for NDA filing process. For an 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 requirements. Apparent knowledge of the guidance detailing the reasons for RTF of a New Drug Application and its review process will save 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 the NDA process, starting from pre-NDA meetings to submission of NDA annual reports and further lifecycle management of the product.

Freyr Expertise and Advantages

Freyr Expertise

  • Strategic support in identifying the optimal Regulatory pathway for an 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 US FDA.
  • 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.
  • 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.