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November 6, 2025
Approximately 5 minutes
Technical Overview: The FDA ANDA Process for Generic Drug Approval
Technical Overview: ANDA Approval Process (Simplified)
The Abbreviated New Drug Application (ANDA) under Section 505(j) of the FD&C Act allows approval of a generic drug by demonstrating pharmaceutical equivalence and bioequivalence (BE) to a Reference Listed Drug (RLD).
1. RLD Identification & Pre-Submission Assessment
- Select the RLD from the Orange Book.
- Evaluate formulation sameness (Q1/Q2) where required, especially for complex products.
- Review exclusivities, perform patent certifications (Paragraph I–IV), and check suitability requirements (21 CFR 314.93).
2. Formulation & CMC Development
- Develop a formulation that is pharmaceutically equivalent to the RLD and aligned with its quality attributes.
- Perform risk assessments per ICH Q8–Q11.
- Establish a control strategy including API characterization, polymorph form, particle size, and excipient compatibility.
3. Analytical Method Development & Validation
- Develop and validate stability-indicating analytical methods as per ICH Q2(R2).
- Conduct method robustness and transfer readiness studies.
- Perform impurity profiling (ICH Q3A/Q3B), evaluate residual solvents (ICH Q3C), and assess elemental impurities (ICH Q3D).
4. Bioequivalence (BE)
- Conduct in-vivo BE studies per 21 CFR 320, or request a BCS-based biowaiver when applicable.
- Use partial or full replicate designs for highly variable drugs.
- Demonstrate BE using pharmacokinetic parameters with 90% CI falling within 80–125%.
5. Stability Studies
- Perform real-time and accelerated studies per ICH Q1A(R2).
- Generate stability data for exhibit/commitment batches, covering all critical quality attributes.
6. ANDA Dossier Preparation (CTD Format)
- Module 1: Administrative information, patent certifications (Paragraph I–IV), and labeling (PLR format).
- Module 2: Quality overall summaries (QOS).
- Module 3: CMC sections for drug substance (3.2.S) and drug product (3.2.P), including characterization, specifications, validation, container closure details, and batch results.
- Module 4: Nonclinical data (only if needed).
- Module 5: BE/biowaiver data.
7. ANDA Submission Under GDUFA
- Submit application via eCTD.
- Pay GDUFA application and facility fees.
- FDA begins filing review, CMC evaluation, labeling review, BE assessment, and facility inspection planning.
8. FDA Interactions
- Respond to Information Requests (IRs), Discipline Review Letters (DRLs), or Complete Response Letters (CRLs).
- Address inspection observations (Form 483) and implement CAPA as needed.
- Ensure proper DMF linkage and maintain a valid Letter of Authorization.
9. Approval or Tentative Approval
- Final Approval: Issued when all scientific requirements are met and no patent/exclusivity barriers exist.
- Tentative Approval: Issued when scientific review is complete but approval is blocked by existing exclusivity.
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