In the world of pharmaceuticals, understanding the ANDA (Abbreviated New Drug Application) submission process is crucial for drug manufacturers seeking approval to market generic drugs.
Evaluation Procedure
The Food and Drug Administration (FDA) thoroughly evaluates each submitted ANDA to determine if it can be received for review.
The concept of “sufficient completeness” plays a vital role in this process. An ANDA is considered sufficiently complete when it contains all the necessary information as per section 505(j)(2)(A) of the FD&C Act and is free from any deficiencies outlined in 21 CFR 314.101(d) and (e).
Upon reviewing the application, the FDA makes a decision to either receive the ANDA, issue an IR (Information Request), or issue an RTR (Refuse to Receive).
The DFR (Division of Filing Review) reviewers utilize the ANDA filing checklist to identify the required and recommended content in an ANDA. This checklist follows the CTD (Common Technical Document) format and backbone, specifying the content of each module of submission.
Common Deficiencies
Some common deficiencies outlined in 21 CFR 314.101(d) and (e) that could lead to an ANDA being considered incomplete.
- Missing or incomplete Form FDA 356h, which is the application form for an ANDA.
- Lack of a U.S. agent signature or countersignature if the form is signed by someone who does not reside or have a place of business within the United States.
- Absence of the name and U.S. address of the authorized official for the ANDA.
- Failure to include a completed and signed Form FDA 3674, which is the establishment and responsible official certification.
- Missing cover letter that summarizes the submission, special requests, and application-specific references.
- Incomplete or missing certifications, such as the Debarment Certification and List of Convictions, Form FDA 3454, or Form FDA 3455.
- Inadequate patent and exclusivity certifications, including missing or incorrect patent information.
- Lack of a list of convictions if there are any convictions to report.
- Failure to provide a right of reference letter for Type II, Type III, or Type IV Drug Master Files (DMFs) referenced in the ANDA.
- Missing basis of submission, such as not referencing the appropriate RLD (Reference Listed Drug) in accordance with the Orange Book at the time of submission.
- Incomplete or missing comparison demonstrating “sameness” or differences from the RLD in terms of conditions of use, active ingredient, route of administration, dosage form, and strength.
- Missing or inadequate draft ANDA and RLD labeling, which should be congruent with the applicant’s patent certification(s) or statement(s).
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Very informative article.