Drug product manufacturers/ANDA holders should utilise the provisions provided by the USFDA for Health Authority interactions to get the concurrence on developmental study expectations, bioequivalence study requirements to ensure the adequacy of the information to be included in the ANDA application.
Interactions with the USFDA can be requested during the development stage of the product to get the concurrence on study designs and also before ANDA submission for complex products. In case of Competitive Generics Therapies (CGT) request, HA 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 to 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