As part of FDARA and GDUFA ll, the USFDA has provided generic drug manufacturers with a dedicated pathway for the development of priority generics to ensure the generic drug product reaches the market in a timely manner. It requires Pre-submission Facility Correspondence (PFC) for expedited development and review of a priority ANDA. ANDA Pre-Submission of Facility Information is intended to provide the information on manufacturing and bioequivalence facilities, including facilities corresponding to Type ll API DMFs reference in the application, which enables the USFDA to assess the necessity of on-site inspection of facilities and if necessary the USFDA can initiate the inspection. This will help ANDA holders/manufacturers to receive the approval early compared to the standard approval timelines.
Freyr's proven generics Regulatory services support clients with pre-submission activities as per the USFDA’s requirements including Pre-submission of Facility Information of Generic Drugs for accelerated review of the priority ANDAs.
Preparation, review and submission of pre-submission Facility Correspondence in alignment with the USFDA’s expectations/guidelines.
Preparation of the relevant Regulatory strategy for timely submission of priority ANDAs
Requesting for ANDA number prior to 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 USFDA’s queries and formulation of appropriate responses to the queries