Generic Drug Approval
Generic Drug Approval - 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,...
06:24
Generic Protocol for Optimization of Heterologous Protein Production Using Automated Microbioreactor Technology
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Cited by 9 •
2017
This manuscript describes a generic approach for tailor-made design of microbial cultivation media. This is enabled by an iterative workflow combining Kriging-based experimental design and microbioreactor technology for sufficient cultivation throughput, which is supported by lab robotics to increase reliability and speed in liquid handling media preparation.
05:10
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Cited by 4 •
2016
Here we describe a protocol using the web-based drug repurposing hypothesis generation tool: "RE:fine Drugs." This protocol can be modified to a user's preferences at the level of the query type (gene, drug or disease) and/or the range of available advanced options.
05:05
Labeling Stem Cells with Ferumoxytol, an FDA-Approved Iron Oxide Nanoparticle
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Cited by 95 •
2011
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.
10:03
Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells
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Cited by 24 •
2013
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...
FAQs
Bioequivalence provides the exposure comparison needed to show that a generic performs comparably to the approved product under defined testing conditions. The assessment considers how the active ingredient is released and the resulting exposure in the body. This pharmacologic evidence helps connect product performance with the expectation of a comparable therapeutic effect in clinical use.
Pharmaceutical equivalence focuses on matching the approved product's active ingredient, strength, dosage form, and route of administration. These attributes establish that both products contain the same active substance in the same intended pharmaceutical presentation. Regulators use this comparison alongside bioequivalence, rather than treating either criterion alone as sufficient, to support consistent therapeutic use.
Quality assessment extends beyond the active ingredient. Regulators examine manufacturing practices, product stability, labeling, and quality controls because each can affect whether a medicine remains consistent from production through use. These elements provide broader assurance that the submitted product can maintain expected characteristics and performance, not merely meet a single equivalence comparison.
An applicant must demonstrate pharmaceutical equivalence and bioequivalence, then provide information on manufacturing practices, stability, labeling, and quality controls. Together, these submissions address the product's composition, in-body exposure, production reliability, storage performance, instructions, and ongoing consistency. Regulators evaluate the combined evidence before authorization, making approval an integrated quality and performance assessment.
Stability information helps show that the product retains its expected characteristics during storage, while labeling communicates how it should be used in clinical practice. Neither replaces equivalence testing. Instead, both support consistent implementation after authorization by addressing the product's condition and the information available to healthcare professionals and patients.
In pharmacology, the process connects established drug performance with broader access. By requiring evidence of comparable exposure and therapeutic effect while reviewing manufacturing and quality controls, it supports authorization of medicines intended to perform like approved products. The availability of lower-cost options can improve access without discarding established standards for safety, efficacy, quality, and clinical use.