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FDA Approved Drugs: Changes to Approved Drugs01:26

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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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Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

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Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
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Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
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In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
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Updated: Mar 21, 2026

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FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications.

Grzegorz Zapotoczny1, Ansh Goyal2, Madison Christmas1

  • 1Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.

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|March 20, 2026
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Summary
This summary is machine-generated.

Pediatric artificial intelligence (AI) medical devices are rare and recently emerged, with longer review times and more clinical trials required. The FDA should standardize AI device labeling for children.

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Area of Science:

  • Medical Technology
  • Artificial Intelligence in Healthcare
  • Pediatric Device Innovation

Background:

  • Artificial intelligence (AI) technologies offer potential for advanced healthcare devices.
  • Limited data exists on the availability and characteristics of AI devices for pediatric patients.
  • Analysis of regulatory submissions is crucial to understand pediatric AI device landscape.

Purpose of the Study:

  • To characterize AI medical devices marketed in the U.S.
  • To identify AI devices with specific pediatric indications.
  • To explore barriers in pediatric AI device innovation.

Main Methods:

  • Retrospective descriptive cross-sectional study.
  • Analysis of FDA AI-Enabled Medical Device List data.
  • Review of marketing submissions from November 1995 to June 2024.

Main Results:

  • Only 4.4% of 952 AI devices had pediatric indications, emerging after 2015.
  • Radiology and neurology were key areas, but 55.6% of clinical areas lacked pediatric AI devices.
  • Pediatric AI devices showed longer FDA review times and higher clinical trial registration rates.

Conclusions:

  • Pediatric AI devices are scarce, recent, and face longer regulatory reviews, indicating a need for more pediatric-specific evidence.
  • Despite similar statutory standards, pediatric AI devices require more evidence generation.
  • Standardizing age labeling and validation for AI-enabled technologies is recommended for the FDA.