NDA Submission, NDA Application, NDA filing, 505(b)(2), 505(b)(1), USFDA

Freyr provides Regulatory Affairs services to the Innovator medicine companies during NDA filing process, starting from pre-NDA meetings to NDA submission and further life cycle management of the medicinal Product.
The New Drug Application (NDA) is an application submitted to the US FDA for approval of a new drug through the 505(b)(1) NDA and 505(b)(2) NDA Regulatory pathway. Most sponsors find NDA submission challenging as they must identify the right Regulatory pathway for their drug development case and define the right Regulatory strategy for the NDA filing process. Moreover, if the information in the NDA submission 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 an ample amount of time for sponsors during the NDA filing process.