Pre-ANDA Submissions - Overview
Pre-ANDA submission is a formal written request for feedback from the US FDA to assist applicants with generics application preparation. Before submitting a generic application for complex generic drug products, manufacturers may require a pre-ANDA meeting with the US FDA to get clarity in developing a complete ANDA application, set the Regulatory expectations in the early product development stage, and reduce the number of review cycles to obtain the ANDA approval.
Additionally, pre-ANDA submission includes requesting a facility self-identification that enables fast, accurate, and reliable inspection of generic drugs globally and facilitates compliance with the Regulatory standards. Before filing a request for a pre-submission meeting, the applicant must choose the correct pathway (product development, pre-submission, or controlled correspondence), provide enough information, and follow the guidance on ANDA meetings with the US FDA.
The Agency has different criteria and timelines to accept the applicant’s request for pre-ANDA submission meetings. Freyr has been assisting its clients with various pre-submission meetings and other administrative activities during and post the meetings for effective ANDA assessment. Our Regulatory experts help clients understand the exact HA requirements and prepare and submit the pre-ANDA meeting packages within the proposed timeframe through the US FDA electronic gateway.
Pre-ANDA Submissions - Freyr Expertise
Submit a pre-ANDA meeting request to the USFDA.
Preparation of a suitable Regulatory strategy (product development, pre-submission, or controlled correspondence) before filing a pre-ANDA submission request.
Requesting scientific advice from Regulatory authorities before ANDA submission for complex products.
Compilation of scientific justification in case of a rejection of the pre-submission meeting request.
Evaluation and preparation of Regulatory response action plan.