FDA's ANDA submission criteria to avoid Refuse to Receive (RTRs)

In recent times, it has been observed that high number of generic drugs are being approved by the United States Food and Drug Administration (US FDA). In parallel, there are also instances of Refuse to Receive (RTR) from the health authority. It might be due to missing or misleading information provided in the Abbreviated New Drug Application (ANDA) Submissions. Though the ANDA applicants are not obliged to provide any preclinical/clinical information for safety and effectiveness, what makes them attracted to RTRs? It might be due to their lack of knowledge on ANDA stage-wise submission criteria or it might be due to their lack of attention towards four components of ANDA submissions. Let’s briefly look into them.

Stage-wise Submission Criteria

As discussed above, ANDA submission involves two stages; each having its own set of submission criteria. The two stages and their submission criteria are as below.

Collecting the Data Required

At this stage, data is collected which proves that a generic drug product is bioequivalent and comparable to an innovator drug product. The data includes:

  • Dosage Form
  • Strength
  • Route of Administration
  • Quality
  • Performance Characteristics and Intended Use

Pre-filing Assessment

Upon receipt of the application, Regulatory authorities perform a pre-filing assessment of the application’s completeness & acceptability and send an “acknowledge letter” to the manufacturer. If the health authority finds any information gaps, and deficiencies, the RTR might be issued based on the below mentioned factors:

  • Inadequate stability data for the generic drug
  • Incomplete information request response
  • Inadequate dissolution
  • Generic drug product, not qualitatively and quantitatively the same as the innovator drug
  • Failure to respond to information request by the Regulatory authorities within the prescribed timeframe

Components of ANDA Submissions

To ensure the ANDA submissions or reviewed and approved on time, applicants are required to monitor and correctly input the below mentioned components. Applicants should take care of:

  • patents and exclusivities
  • labeling
  • product quality
  • bioequivalence

To conclude, with all the components taken care of, the ANDA applications should go through proper review cycles before submissions and approvals. Thus, to fulfil any deficiencies and avoid RTRs. How accurate is your review? Evaluate with an expert. Stay informed. Stay Compliant.

Would you like to know more about FDA’s RTR standards for ANDA submissions? Read through one of Freyr’s thought leadership articles published in pharmaceutical online