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505(b)(2)

505(b)(2)

The 505(b)(2) NDA pathway offers a streamlined approach to drug approval, enabling the development of innovative products by leveraging existing data. This pathway allows for the submission of a new drug application that includes full reports of investigations of safety and effectiveness, with at least some of the information required for approval coming from studies not conducted by or for the applicant.

At Viora, we specialize in guiding clients through the 505(b)(2) process, offering: 

  • Regulatory Strategy Development: Our experts assist in designing regulatory strategies that align with your product's unique characteristics and market goals, optimizing the use of existing data to support your application.
  • Clinical Study Design and Management: We provide comprehensive support in designing and managing clinical studies, ensuring they meet FDA requirements and effectively bridge any data gaps.
  • Regulatory Submission Preparation: Our team prepares and submits all necessary documentation, ensuring compliance with FDA guidelines and facilitating a smoother approval process.
  • Leveraging the 505(b)(2) pathway can lead to reduced development timelines and costs, bringing your products to market more efficiently. Contact us to learn how our expertise can support your regulatory needs.