Prior Approval Supplement
Prior Approval Supplement - Related Videos
01:26
FDA Approved Drugs: Changes to Approved Drugs
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2025
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Labeling Stem Cells with Ferumoxytol, an FDA-Approved Iron Oxide Nanoparticle
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We describe a technique for labeling and tracking stem cells with FDA-approved, superparamagnetic iron oxide (SPIO), ferumoxytol (Feraheme). This cellular imaging technique that utilizes magnetic resonance (MR) imaging for visualization, is readily accessible for long-term monitoring and diagnosis of successful or unsuccessful stem cell engraftments in patients.
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Dietary Supplementation of Polyunsaturated Fatty Acids in Caenorhabditis elegans
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Cited by 59 •
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Caenorhabditis elegans is a useful model to explore the functions of polyunsaturated fatty acids in development and physiology. This protocol describes an efficient method of supplementing the C. elegans diet with polyunsaturated fatty acids.
10:03
Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells
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Rescue of recombinant arenaviruses from cloned cDNAs, an approach referred to as reverse genetics, allows researchers to investigate the role of specific viral gene products, as well as the contribution of their different specific domains and residues, to many different aspects of the biology of arenavirus. Likewise, reverse genetics techniques in FDA-approved cell lines (Vero) for vaccine development provides novel possibilities for the generation of effective and safe vaccines to combat human...
10:29
The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression
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FAQs
Prior review allows the regulatory agency to assess whether the proposed modification could affect the product’s identity, strength, quality, purity, or performance. This timing prevents an important change from being introduced before its supporting evidence is examined. It also preserves alignment between the product used clinically and the conditions described in the approved application.
The submission links new information about manufacturing, processes, facilities, specifications, or labeling to the product’s existing approved status. This relationship gives reviewers a basis for determining whether the change remains consistent with established product characteristics and clinical use. The result is an evidence-based evaluation rather than an isolated assessment of the modification.
Review centers on whether the change could adversely affect identity, strength, quality, purity, or performance. These characteristics provide a scientific framework for evaluating diverse modifications, including changes to manufacturing practices or specifications. Considering them together helps maintain product consistency while allowing controlled evolution during the product’s postapproval lifecycle.
A sponsor should provide supporting information relevant to the proposed change, selecting data that explain its effect on manufacturing, processes, facilities, specifications, or labeling. The submission should make the relationship between the modification and the approved application clear. This organization enables the agency to judge potential effects on product quality and clinical use.
The sponsor first identifies a significant postapproval change and prepares supporting information describing the affected product or application elements. The submission then goes to the regulatory agency for review. Implementation follows only after authorization, creating a controlled sequence that connects scientific documentation, regulatory decision-making, and continued use of the approved medical product.
It is relevant when an approved medical product undergoes a substantial change that could influence how it is manufactured, characterized, or described for clinical use. By requiring review of these changes, the process supports product lifecycle management without losing consistency between approved materials, manufacturing practices, specifications, labeling, and the product used in clinical settings.