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# Guidance on Considerations for Drug Quality Assessments
- URL: https://www.fdaweb.com/guidance-on-considerations-for-drug-quality-assessments/
- Published: 2022-05-09T12:00:00.000Z
- Updated: 2026-09-14T17:43:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151771

FDA has released a [draft guidance](https://www.fda.gov/media/158204/download?ref=fdaweb.com) entitled “Benefit-Risk Considerations for Product Quality Assessments,” which describes the agency’s benefit-risk principles used when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted in NDAs/BLAs, in addition to other information (e.g., inspection findings) available during the review. “This guidance discusses how FDA assesses risks, sources of uncertainty, and possible mitigation strategies for a product quality-related issue and how those considerations inform FDA’s understanding of the potential effect on a product,” the agency says. "The product quality assessment determines whether an applicant’s product development studies, manufacturing process, and control strategy will consistently result in a finished product of acceptable quality when manufactured at the facilities named in the application.”

The document also discusses how unresolved product quality issues may be addressed when FDA makes a regulatory decision. It says most of the time, the agency will not approve an application when unresolved quality issues remain. However, in rare situations, FDA says it may approve such an application if the “residual risk posed by the unresolved quality issue may be outweighed by the benefits of the product and of having the product on the market more quickly. In situations like this, the agency may allow certain information to be submitted postapproval.”

For example, FDA could allow a firm to submit postapproval confirmatory photostability data to address a change in film-coat composition that affects shading of film-coat color. There could also be a case when there is an unmet medical need that would warrant allowing such information to be submitted postapproval. “In such cases, FDA may use a quality postmarketing agreement (QPA) for a product quality issue,” it says. “A QPA is not a substitute for an applicant satisfying statutory and regulatory requirements for approval or licensure and should not be part of an applicant’s planned development program.”