FDA offers insight into product quality assessment principles

Regulatory NewsRegulatory News | 11 May 2022 |  By 

The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications (NDA), biologics license applications (BLAs), and supplements.
The draft guidance, released on 10 May, provides details on possible mitigation strategies for quality issues and the circumstances under which unresolved quality issues could be addressed during a public health emergency or widespread drug shortage.
When looking at product quality assessment of marketing applications, FDA considers the interplay between therapeutic context, potential benefits, and quality-related risk considerations.
“A greater understanding of the patient population, disease or condition, and whether there is unmet medical need helps to frame for the product quality assessor and team the importance of the product within the overall therapeutic armamentarium that is available to patients and health care providers and may provide context used to evaluate the potential significance of risks identified during the assessment to inform FDA’s recommendation regarding the risk mitigation or reduction,” FDA wrote in the draft guidance.
The agency also examines potential risks from a product quality issue using the following principles:
  • Risk-based considerations related to therapeutic context.
  • Extent of the impact on safety and/or effectiveness.
  • Totality of the product quality information.
  • Inspection findings.
  • Other considerations that could affect the product quality assessment, such as the need for additional testing.
  • Possible mitigation strategies.
FDA cautioned that any potential mitigation strategy must not introduce new product quality issues or worsen previously identified issues.
While unresolved quality issues typically mean that FDA will not approve the application, there are some exceptions in which the risk posed by the unresolved issue may be outweighed by the benefit of the product or the ability to bring it market quickly, such as a product that addresses an unmet medical need. In those cases, FDA may allow some information to be submitted after approval. These types of quality post-marketing agreements (QPA) are generally not applicable for generic drug products approved through an abbreviated new drug applications (ANDA) unless there is a public health emergency or pervasive drug shortage.
“The decision that a QPA would be appropriate for a particular ANDA would likely consider the type and extent of information that will be expected postapproval to resolve the issue and potential effect on similarly situated ANDAs. A QPA does not relieve a generic drug applicant from satisfying all the statutory and regulatory requirements for approval of an ANDA, does not correct a deficient ANDA, and should not be part of the applicant’s planned development program,” according to the draft guidance.
Draft guidance


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