US FDA Health Authority Interactions - Overview
Drug product manufacturers/ANDA holders should utilize the provisions in the US FDA for Health Authority interactions to harmonize developmental study expectations and bioequivalence study requirements and ensure the adequacy of the information to be included in the ANDA application.
US agent interactions with the US FDA can happen during the development stage of the product to get concurrence on the study designs before the ANDA submission for complex products. In case of Competitive Generics Therapies (CGT) requests, the US FDA agent interactions will be allowed for pre-development, FDA pre-submission meetings, and mid-review cycle meetings to discuss the development plans, the content, and the format of their potential ANDA applications. The US FDA helps applicants identify the risks and weaknesses related to the ANDA application in advance so that the appropriate risk-mitigation strategies can be implemented in a timely fashion to avoid market delays.
Freyr, with its comprehensive services, helps clients get the most out of their interactions with the US FDA. Our Regulatory experts assist applicants in various US FDA Health Authority interactions.
US FDA Health Authority Interactions - Expertise
- Preparation and submission of controlled correspondence to the US FDA for confirmation on the composition of the product.
- Complete evaluation of client expectations and provision of strategic guidance for interactions with the US FDA.
- Preparation of meeting packages, documents, meeting plan, preparation of meeting minutes, and action plan for next steps.
- Preparation of response for additional information request by the US FDA.
- Follow-up activities and post-meeting requirements like submission of meeting minutes and development of program strategy based on the US FDA Health Authority interactions.
- Evaluate the HA queries and formulate the appropriate responses.
