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  1. CDER Small Business & Industry Assistance (SBIA)

Transcript: How FDA is Helping the Generic Industry Submit More Complete Applications

Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series

Today’s topic: How FDA is helping the Generic Industry submit more complete applications

The FDA is working to make the Abbreviated New Drug Application submission and assessment process more efficient by providing guidance to industry. FDA is also establishing internal practices to help reduce the number of review cycles for an Abbreviated New Drug or ANDA to attain approval. The newly released draft guidance for industry, Good ANDA Submission Practices, and the Manual of Policies and Procedures, or MAPP, Good Abbreviated New Drug Application Assessment Practices, apply insights gained through the first five years of the Generic Drug User Fee Amendments, or GDUFA, program.

Until now, approximately half of all ANDAs with GDUFA review goals required at least three review cycles to reach approval or tentative approval -- an inefficient and resource-intense process.

The new guidance lists common, recurring deficiencies that may lead to a delay in the approval of an ANDA, such as issues with patents and exclusivities, labeling, product quality, and bioequivalence. It also provides recommendations to applicants on how to avoid these deficiencies. The goal is to minimize the number of cycles necessary for approval.

The following are highlights of FDA’s recommendations to prevent applicant submission deficiencies:

  • Submit timely written documentation of sending and receiving notice of a paragraph IV certification, and whether the patent owner and/or exclusive patent licensee filed a legal action within 45 days of receipt of the certification notice.
  • Monitor the Orange Book and address newly-listed and revised patents and exclusivities. Applicants must not submit a paragraph IV certification to the ANDA for a newly-listed patent earlier than the first working day after the day the patent is published in the Orange Book.
  • Submit the required notification of commercial marketing to FDA within the 30-day time frame.
  • Ensure that the draft version of container labels and carton labeling reflect the content as well as accurate representation of the formatting factors that will be used with the final printed labeling.
  • Ensure that the color and/or format of container labels and carton labels are adequately differentiated from other pending and approved products in the applicant’s product line. 
  • Ensure that the package type for ANDAs of parenteral drug products are the same as the approved reference listed drug; the strength is clearly displayed and expressed on the container label; and that the ferrules and cap overseals of injectable drug products clearly convey cautionary statements.
  • For the drug substance, drug master file or DMF holders should provide complete information on their active pharmaceutical ingredient, or API, and the manufacturing process, including a flow chart for every stage. DMF holders should include API characterization information, including information on potential impurities, justification for their specification for isolated intermediates, and a clear rationale that includes critical quality attributes when establishing drug substance specifications. They should also communicate with ANDA applicants regarding when amendments will be submitted to the DMF, as unsolicited amendments that affect the adequacy of the DMF to support approval of the ANDA may extend GDUFA goals or create new review goals.
  • For the drug product, applicants should include information in their ANDAs to support the selection and rationale for their critical quality attributes, and should submit a complete method development and validation report when an in-house dissolution testing method is used.
  • FDA has provided recommendations for the identification, control, and qualification of impurities.
  • FDA has also provided recommendations for the justification of the exposure level and safety of inactive ingredients and validation of analytical methods.
  • Applicants should also provide complete manufacturing facility information on Form 356h as well as complete facility and process information within Module 3 of the application. They should also communicate with any contract manufacturing facilities about current good manufacturing practices-related roles and changes in inspection status.

And finally, applicants should:

  • Provide complete bio-analytical study reports and bio-analytical methodology validation data along with accurate and complete information in their model summary tables.   
  • Provide justification and support data if there is a deviation from a relevant product-specific guidance, and
  • Provide justification and documentation for differences permissible under FDA regulations between the formulation of the proposed generic drug product and the RLD.

The new guidance does not include a comprehensive list of all deficiencies identified during ANDA assessment. It is each applicant’s responsibility to submit a high-quality, complete application that meets the standards for approval in the first cycle. 


FDA has also established a MAPP of good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality, with the goal of increasing operational efficiency and effectiveness while decreasing the number of approval cycles. 

The MAPP establishes that assessment teams should use templates and assessment tools provided by the sub-disciplines that focus the primary assessment of quality, bioequivalence, or labeling data or information on the critical attributes of the application.  Note that the term assessment is used in place of review to refer to the process of evaluating and analyzing submitted data and information.

The assessment document establishes that FDA will clearly communicate to applicants what deficiencies must be corrected for their ANDA’s approval. It also clarifies the roles and responsibilities of primary and secondary assessors to reduce duplicative and unnecessary work.

These changes are expected to expand access to generic medicines and enable FDA experts to focus more of their attention on novel or challenging scientific and policy issues in the development and assessment of generic drug products.

In all, FDA remains committed to increasing prescription drug competition in the marketplace, and to facilitating the entry of safe, effective, high-quality, and affordable generic drugs.

A link to the full SBIA Chronicle article and more information about CDER’s SBIA Program may be found at: www.fda.gov/cdersbia. Thanks for tuning in!


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