ANDA Pre-Submission Facility Correspondence - Overview
As part of FDARA and GDUFA ll, the US FDA has provided generic drug manufacturers with a dedicated pathway for the development of priority generics to ensure the generic drug product reaches the market promptly. It requires ANDA Pre-submission Facility Correspondence (PFC) for expedited development and review of a priority ANDA. Pre-submission ANDA data is intended to provide information on the manufacturing and bioequivalence facilities, including facilities corresponding to Type ll API DMF references in the application, which enables the US FDA to assess the necessity of an on-site inspection of the facilities and, if necessary, initiate the inspection. This will help ANDA holders/manufacturers to receive the approval early when compared to the standard approval timelines.
Freyr's proven generics Regulatory services support clients with pre-submission activities per the US FDA’s requirements, including pre-submission of facility information of generic drugs, for an accelerated review of the priority ANDAs.
ANDA Pre-Submission Facility Correspondence - Expertise
- Preparation, review, and submission of ANDA pre-submission facility correspondence in alignment with the US FDA’s expectations/guidelines.
- Preparation of the relevant Regulatory strategy for the timely submission of priority ANDAs.
- Requesting for the ANDA number before the ANDA pre-submission of facility information.
- Requesting for facility self-identification.
- Regulatory assessment and identification of potential gaps in the documents and providing necessary guidance.
- Pre-submission communications with the HA to confirm the formulation combinations of the drug product.
- Evaluate the US FDA’s queries and formulate appropriate responses to them.
