ANDA Tips From the FDA

How the generic drug industry can submit more complete applications

By Renu Lal, Pharm.D., CDER’s Small Business and Industry Assistance (SBIA), Division of Drug Information (DDI), and Lisa Bercu, Regulatory Counsel, CDER’s Office of Generic Drugs (OGD)

As part of the FDA’s efforts to encourage generic competition through implementation of the Drug Competition Action Plan, the agency is working to make the Abbreviated New Drug Application (ANDA) submission and assessment process more efficient and effective.

Earlier this year, the Office of Generic Drugs (OGD), in coordination with the Office of Pharmaceutical Quality (OPQ) and other offices in the FDA’s Center for Drug Evaluation and Research (CDER), released a new guidance for industry and established more streamlined internal practices to help reduce the number of review cycles for ANDA approval. The draft guidance, Good ANDA Submission Practices, and the Manual of Policies and Procedures (MAPP) 5241.3, Good ANDA Assessment Practices, apply insights gained through the implementation of the first five years of the Generic Drug User Fee Amendments (GDUFA) program to improve application quality and increase assessment efficiency.

Until now, approximately half of all ANDAs with GDUFA review goals required at least three review cycles to reach approval or tentative approval. The reauthorization of GDUFA (GDUFA II) improves the predictability and transparency of ANDA assessments by fostering the development of high-quality submissions and resubmissions. These enhancements should help to get generic products to market more quickly.

GOOD ANDA SUBMISSION PRACTICES GUIDANCE
The draft guidance describes common deficiencies in ANDA submissions that may lead to delays in approval. It also provides recommendations to applicants on how to avoid these deficiencies. Key recommendations include:

Patent and Exclusivity

  • Submit timely written documentation of the sending and receipt of notice of a paragraph IV certification.
  • Monitor the Orange Book and quickly address newly listed patents, revised patents, and exclusivities.
  • Submit required notification of commercial marketing to FDA within the designated 30-day time frame.

Labeling

  • Ensure that draft versions of container labels and carton labeling “reflect the content, as well as an accurate representation of the layout, text size and style, color, and other formatting factors that will be used with the [final printed labeling].”
  • Ensure the color and/or format of container labels and carton labeling are adequately different from other pending/approved products in applicant’s product line.

FDA has released new guidance for industry and has established more streamlined internal practices to speed ANDA review and approval.

Product Quality

  • Submit complete drug substance information in a drug master file (DMF) or in Module 3.2.S.2.2, including characterization of the API with all potential impurities and justification for their specification.
  • Follow FDA and ICH guidances to provide a complete product quality evaluation.
  • Provide complete manufacturing facility information in Form FDA 356h.
  • Communicate with contract manufacturing facilities about CGMP-related roles and changes in inspection status.

Bioequivalence

  • Provide complete bioanalytical study reports and methodology validation data, plus accurate and complete information for model summary tables.
  • If there is a deviation from a relevant product-specific guidance, provide the justification and supportive data.

MAPP — GOOD ANDA ASSESSMENT PRACTICES
The FDA has also established a MAPP with good ANDA assessment practices for OGD and OPQ to improve internal operations. The MAPP clarifies the responsibilities of primary assessors, secondary assessors, and division directors, which will reduce duplicative/unnecessary work.

We expect these changes will allow the FDA to focus more attention on novel or challenging scientific and policy issues associated with generic drug products. The FDA remains committed to increasing competition in the prescription drug marketplace, and facilitating the entry of safe, effective and affordable generic drugs.

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