Introduction to New Drug Application (NDA) Process
The New Drug Application (NDA) process is a crucial step in the approval of pharmaceutical drugs intended for human use by the United States Food and Drug Administration (US FDA). The regulatory framework for the approval of new drugs is provided by the US Federal Food, Drug, and Cosmetic Act. The NDA process includes the submission of comprehensive reports on the safety and efficacy of the drug.
505(b)(1) NDA Pathway
The 505(b)(2) NDA pathway is a regulatory option that allows a sponsor to utilize data from studies that were not conducted by the applicant and for which the applicant has not obtained the right of reference. To pursue this pathway, the application should include complete reports on the safety and effectiveness of the drug. Typically, this pathway is used when developing drugs with modifications to their dosage form, strength, or route of administration that have already been evaluated and approved by the FDA as part of other NDAs.
505(b)(2) NDA Pathway
The 505(b)(2) NDA pathway is an alternative regulatory option that allows sponsors to use data from studies that were not carried out by them and for which they do not have the right of reference. However, the application must include complete reports on the drug’s safety and efficacy. Typically, this pathway is utilized for drugs with modifications to their dosage form, strength, or route of administration that have already undergone evaluation and approval by the FDA under other NDAs.
Understanding FDA Regulations and Identifying the Right Regulatory Pathway
Identifying the right regulatory pathway for the NDA process can be the most challenging part of the process for most sponsors. The FDA provides guidance to sponsors on the regulatory requirements for drug development and approval, including the submission of NDAs. This guidance can be visible on the FDA’s website. They help sponsors to understand the FDA regulations and identify the right regulatory pathway for their drug development case.
Defining the Right Regulatory Strategy for NDA Filing Process
In addition to understanding the regulatory requirements, sponsors must define the right regulatory strategy for the NDA filing process. This includes developing a comprehensive plan for the development and submission of the New Drug Application, which takes into account the regulatory pathway chosen, the clinical trial design, and the data collection and analysis plan. Templarpharma assists sponsors in defining the right regulatory strategy for their NDA filing process.
Refusal to File (RTF) of an NDA
If the sponsor fails to submit adequate information required as per federal regulations. The US FDA may Refuse to File (RTF) the New Drug Application. This means that the sponsor cannot move forward with the New Drug Application process unless additional information is submitting to comply with the agency requirements. Understanding the reasons for RTF of an NDA and its review process can save investment. And time for sponsors during the NDA filing process. Templarpharma provides guidance to sponsors to ensure that the necessary information is provided to prevent RTF.
Regulatory Support for the NDA Process
Templarpharma provides end-to-end regulatory support for the New Drug Application process. Starting from pre-NDA meetings to the submission of New Drug Application annual reports and further lifecycle management of the product. The company’s team of experts assists sponsors in understanding FDA regulations. Identifying the right regulatory pathway, and defining the right regulatory strategy for the New Drug Application filing process. They also help sponsors to avoid RTF by ensuring the submission of adequate information required as per federal regulations. Templarpharma’s regulatory support enables sponsors to streamline their NDA process and bring their products to market faster.
Expertise required
Templarpharma provides a range of regulatory support services to help companies navigate the New Drug Application (NDA) submission process. These services include:
- Strategic guidance on identifying the optimal regulatory pathway for an NDA submission
- Expert advice on availing agency support via expedited programs, such as Fast Track designation, Breakthrough Therapy designation, Accelerated Approval process, and Priority Review designation
- Support for pre-submission meetings, including briefing package preparation and meeting representation to discuss scientific issues with the US FDA
- Extensive knowledge of federal regulations and submission pathways, including 505(b)(1), 505(b)(2), and 505(j)
- Gap analysis of developmental data/source data against NDA submission requirements. And guidance to sponsors on a risk mitigation plan for identified regulatory gaps
- Compilation and technical review of 505(b)(1) and 505(b)(2) packages. Including preparation of Module 1 documents and other NDA application forms, publishing, and submission of applications in the eCTD format via the FDA ESG
- We offer templates for New Drug Applications that contain all the technical details needed for preparing. And submitting an NDA through the electronic Common Technical Document (eCTD) system.
- We can help you develop a plan to respond to any regulatory queries or requests for information from the US Food and Drug Administration (FDA). As well as prepare and submit your responses on time.
- Our regulatory experts can assist you in all pre- and post-submission interactions with the FDA throughout the NDA approval process.
- We provide support for managing the lifecycle of your approved NDA. Including preparing and submitting any necessary supplements, changes being in effect within 30 days (CBE 30), changes being in effect (CBE), annual reports, etc.
- We can help you develop a strategy and provide submission support for managing Complete Response Letters (CRLs) received from the FDA in response to your NDA.