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Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

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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 a challenge in...

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Updated: May 29, 2026

Guidelines for Elective Pediatric Fiberoptic Intubation

Guidelines for Elective Pediatric Fiberoptic Intubation

Published on: January 17, 2011

Pediatric regulatory initiatives.

Steven Hirschfeld¹, Agnes Saint-Raymond

¹National Children's Study Eunice Kennedy Shriver, National Institute of Child Health and Human Development, Bethesda, MD 20892, USA. hirschfs@mail.nih.gov

Handbook of Experimental Pharmacology

|September 2, 2011

Summary

This summary is machine-generated.

Government initiatives since the 1990s have spurred pediatric drug development through incentives and mandates. Continued evolution and collaboration are key to aligning pediatric therapeutics with adult treatments, ensuring safety and efficacy for children.

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Area of Science:

Pediatric pharmacology
Regulatory science
Drug development policy

Background:

Since the 1990s, government actions have aimed to improve pediatric drug development.
These actions combine financial incentives with regulatory mandates.
The goal is to address historical gaps in pediatric therapeutic options.

Observation:

Initiatives have successfully increased activity and interest in pediatric medicinal products.
Regulatory agencies are developing cooperative programs.
Experience gained from these initiatives informs ongoing evolution.

Findings:

A combination of incentives and mandates has proven effective in stimulating pediatric drug development.
Regulatory programs are becoming more robust through collaboration.
The landscape of pediatric therapeutics is evolving.

Implications:

A multidimensional approach is essential for pediatric drug development.
Aligning pediatric therapeutics with adult treatments is a critical goal.
Minimizing risk while maximizing benefit for vulnerable pediatric populations is paramount.