Abbreviated New Drug Application

Abbreviated New Drug Application - Overview

The Abbreviated New Drug Application (ANDA) is an application submitted to the United States Food and Drug Administration (US FDA) for the review and approval of a generic drug demonstrating bioequivalence against an already-approved innovator drug so that the generic drug can be used as a safe, effective, and low-cost alternative to the brand-name drugs.

Applicants must file the ANDA submissions based on the content and format, Refuse-to-Receive (RTR) standards, and other US FDA guidelines, particularly the 505(j), for successful ANDA approval during the first review cycle.

Freyr, with extensive experience in registration activities for Abbreviated New Drug Applications, offers end-to-end ANDA submission services for manufacturers/sponsors and, thus, is a preferred Regulatory partner to ensure Market Authorization Application (MAA) approval right the first time.

Abbreviated New Drug Application - Freyr Expertise

  • 01

    Preparation of Regulatory roadmap strategy for ANDA filing.

  • 02

    Regulatory consultation during the drug development stage in the selection of the Reference Listed Drugs (RLDs), evaluation of excipients against the IIG database for oral drugs, and controlled correspondence submission for Q1/Q2 sameness for sterile products.

  • 03

    Review of quality-by-design protocols and reports and guidance on stability and bioequivalence studies for ANDA submission.

  • 04

    Support in pre-ANDA-submission administrative activities like a request for the ANDA number, Data Universal Numbering System (DUNS) number, the FDA Establishment Identifier (FEI) number, labeler code, etc.

  • 05

    Pre-submission FDA interactions and walkthrough support in control correspondences.

  • 06

    Gap analysis/Regulatory assessment of generated source data for Regulatory adequacy.

  • 07

    Compilation of the quality dossier per the current FDA and RTR requirements, publishing, and ANDA submission via the FDA Electronic Submission Gateway (ESG).

  • 08

    Preparation of strategic risk mitigation plans for error-free ANDA submissions to ensure zero RTR.

  • 09

    Regulatory response strategy and preparation for the response with scientific justifications for Health Authority queries (IRs/DRL/CRLs) during the ANDA filing process.

  • 10

    Critical support in resolving RTR issues for streamlined Abbreviated New Drug Application processes.

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