Drug product manufacturers/ANDA holders should utilize the provisions in the USFDA for Health Authority interactions to get the concurrence on developmental study expectations and bioequivalence study requirements to ensure the adequacy of the information to be included in the ANDA application.
US agent interactions with the USFDA can be requested during the development stage of the product to get the concurrence on study designs and before the ANDA submission for complex products. In case of Competitive Generics Therapies (CGT) requests, the US agent interaction will be allowed by the USFDA for pre-development, pre-submission, and mid review cycle meetings to discuss the development plans as well as the content and format of their potential ANDA applications. The USFDA helps applicants identify the future risks and weaknesses related to the plan or ANDA application in advance, so that the appropriate risk-mitigation strategies can be implemented in a timely fashion without any market delays.
Freyr, with its comprehensive services, helps clients to get most out of the interactions with the USFDA. Our Regulatory experts assist applicants in various types of Health Authority interactions.
Preparation and submission of Controlled Correspondence with the USFDA for confirmation on the composition of the product.
Complete evaluation of client expectation and providing strategic guidance for generic pharmaceuticals interactions with the USFDA.
Preparation of meeting packages, documents, meeting plan, preparation of meeting minutes, and action plan for next steps.
Preparation of response for additional information request from the USFDA.
Follow-up activities and post-meeting requirements like submission of meeting minutes and development of program strategy based on the Health Authority interactions.
Evaluate query and formulation of appropriate response.