Office of New Drugs Unit List: Pediatric Regulations (2023)

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Pediatric Drug Legislation

Drug Regulation

In drug regulation, pediatric patients are defined as children younger than age 17. The age cohorts are not defined in the regulations but should be based on scientific rationale -- for example, the metabolism of a critical enzyme, clinical endpoints and the ability to swallow the formulation. An example of pediatric cohorts:

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  • Neonates -- birth to age less than 1 month
  • Infants -- age 1 month to less than 2 years
  • Children -- ages 2 to less than 12 years
  • Adolescents -- ages 12 to less than 17 years
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Office of New Drugs Unit List: Pediatric Regulations (1)

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What does FDA consider pediatric? ›

Infants - 29 days to less than 2 years. Children - 2 years to less than 12 years.

What are the 5 child stages? ›

What Are the Five Stages of Early Childhood Development?
  • In general, the five stages of early childhood development are as follows:
  • Newborn.
  • Infant.
  • Toddler.
  • Preschooler.
  • School-age child.
Jul 8, 2022

What age limit is considered as a pediatric case? ›

After the neonatal phase, your child will go through infancy, the toddler stage, then early and middle childhood. By the time they are 12, they will be an adolescent, but they won't be considered fully adult until they are 21. In most cases, your child can switch to an adult physician after the age of 18.

What is the exclusivity criteria for pediatric drugs? ›

Pediatric exclusivity does not accrue only to the product that was studied in the pediatric population. It attaches to all the applicant's formulations, dosage forms, and indications for products with existing marketing exclusivity or patent life that contain the same active moiety.

Is 12 years old considered pediatric? ›

1. With few exceptions, patients 18 years and older should be admitted to an adult service and patients less than 18 years should be admitted to a pediatric service.

How does the FDA approve drugs for children? ›

A drug company may submit a proposal to the FDA to conduct pediatric studies. If the FDA agrees that studying a drug may produce health benefits for children, the agency will issue a "Written Request" addressing the type of studies to be conducted, study design and goals, and the age groups to be studied.

At what age is a child fully developed? ›

Under most laws, young people are recognized as adults at age 18. But emerging science about brain development suggests that most people don't reach full maturity until the age 25.

What is a child called at 5 years old? ›

Preschoolers (3-5 years of age)

Is a 5 year old still a baby? ›

Infants can be considered children anywhere from birth to 1 year old. Baby can be used to refer to any child from birth to age 4 years old, thus encompassing newborns, infants, and toddlers.

At what age can a child make medical decisions? ›

Children under the age of 18 are generally considered as not having the capacity to make health care decisions for themselves and cannot give informed consent. Parents or legal guardians are presumed to be the appropriate decision-makers for their minor children.

Can a pediatrician diagnose ADHD? ›

Your pediatrician will determine whether your child has ADHD using standard guidelines developed by the American Academy of Pediatrics. These diagnosis guidelines are specifically for children 4 to 18 years of age. It is difficult to diagnose ADHD in children younger than 4 years.

How much does a pediatrician make? ›

R65,766 (ZAR)/yr

The average pediatrician gross salary in South Africa is R1,569,592 or an equivalent hourly rate of R755. In addition, they earn an average bonus of R65,766. Salary estimates based on salary survey data collected directly from employers and anonymous employees in South Africa.

What is the Clark's rule for pediatric? ›

Clark's rule equation is defined as the weight of the patient in pounds divided by the average standard weight of 150 pounds (68 kg) multiplied by the adult dose of a drug equals the pediatric medication dose, as is demonstrated below: (Weight* divided by 150 lbs.) x Adult Dose** = Pediatric Dosage.

What are the 4 phases for getting new drug approved in the US? ›

Information For
  • Step 1: Discovery and Development.
  • Step 2: Preclinical Research.
  • Step 3: Clinical Research.
  • Step 4: FDA Drug Review.
  • Step 5: FDA Post-Market Drug Safety Monitoring.
Jan 4, 2018

What is the criteria for new drug application? ›

New Drug Application (NDA)
  • Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
  • Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
Jan 21, 2022

Is 14 considered pediatric? ›

Patients who are known to be less than 15 years of age but whose weight exceeds 36 kg may still be considered pediatric patients given their chronological age; however weights will then need to be estimated and adult dosages should be used.

Is age 14 a childhood? ›

The ages 11 through 14 years are often referred to as early adolescence. These years are an exciting time of many varied and rapid changes. Your child grows taller and stronger and also starts to feel and think in more mature ways. You may feel amazed as you watch your child begin to turn into an adult.

Is a 10 year a child? ›

As children reach the age of 10, many will start to think of themselves as being almost teenagers. While some 10-year-olds will start looking and acting more mature, others will remain more child-like, both physically and emotionally. "Ten-year-olds are emerging adolescents.

What are FDA approval requirements? ›

New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.

What are the 5 steps for FDA approval? ›

FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

What are the 3 phases of FDA approval? ›

There are three primary phases of the approval process: pre-clinical trials, clinical trials, and new drug application review.

What are the age groups of the 4 stages of development? ›

Piaget's Cognitive Development Theory
  • Sensorimotor stage (0–2 years old)
  • Preoperational stage (2–7 years old)
  • Concrete operational stage (7–11 years old)
  • Formal operational stage (11 years old through adulthood)
May 3, 2021

How do you categorize age groups? ›

Age Categories, Life Cycle Groupings
  1. Children (00-14 years) 00-04 years. 110. 00-04 years. 05-09 years. 120. 05-09 years. ...
  2. Youth (15-24 years) 15-19 years. 211. 15-17 years. 212. 18-19 years. ...
  3. Adults (25-64 years) 25-29 years. 310. 25-29 years. 30-34 years. 320. ...
  4. Seniors (65 years and over) 65-69 years. 410. 65-69 years. 70-74 years. 420.
May 8, 2017

What are the stages of age groups? ›

Life stages
  • Prenatal/infancy. From conception through the earliest years of life or babyhood. ...
  • Early childhood. The time in a child's life before they begin school full-time. ...
  • School age. The years from kindergarten through middle school. ...
  • Transition to adulthood. ...
  • Adulthood. ...
  • Aging.

What are the age group classifications? ›

  • Neonates or newborns (birth to 1 month)
  • Infants (1 month to 1 year)
  • Children (1 year through 12 years)
  • Adolescents (13 years through 17 years. They may also be referred to as teenagers depending on the context.)
  • Adults (18 years or older)
  • Older adults (65 and older)*
Sep 2, 2022

What are the 7 stages of child development? ›

Infancy (neonate and up to one year age) Toddler ( one to five years of age) Childhood (three to eleven years old) - early childhood is from three to eight years old, and middle childhood is from nine to eleven years old. Adolescence or teenage (from 12 to 18 years old)

What are the 7 age groups? ›

  • Infants (0-1 year)
  • Toddlers (1-2 years)
  • Toddlers (2-3 years)
  • Preschoolers (3-5 years)
  • Middle Childhood (6-8 years)
  • Middle Childhood (9-11 years)
  • Young Teens (12-14 years)
  • Teenagers (15-17 years)

What are the 3 categories of age distribution? ›

It is common in demography to split the population into three broad age groups:
  • children and young adolescents (under 15 years old)
  • the working-age population (15-64 years) and.
  • the elderly population (65 years and older)

What are the 8 age groups? ›

What are the Stages of Life?
  • Infant = 0-1 year.
  • Toddler = 2-4 yrs.
  • Child = 5-12 yrs.
  • Teen = 13-19 yrs.
  • Adult = 20-39 yrs.
  • Middle Age Adult = 40-59 yrs.
  • Senior Adult = 60+
Oct 9, 2015

What are the 3 Old age categories? ›

Although there are different ways to classify this population, some studies have classified elderly adults between the ages of 65 and 74 years as youngest-old, those between ages 75 and 84 years as middle-old, and those aged over 85 years as oldest-old [5].

What are 4 year olds called? ›

Preschooler (3-5 years old) | CDC.

What are 6 year olds called? ›

3–5 years (Preschooler) 6- 9 years (Child) 10–12 1/2 years (Preteen or “Tween”)

What is the most important age group? ›

Recent brain research indicates that birth to age three are the most important years in a child's development.

What are 30 to 40 year olds called? ›

A person between 20 and 29 is called a vicenarian. A person between 30 and 39 is called a tricenarian. A person between 40 and 49 is called a quadragenarian.

What is a 10 year old classified? ›

Kids between 8 and 12 are called “tweens” because they are in between children and teenagers. It's very normal for kids this age to start to move from being very close to parents to wanting to be more independent. But they still need a lot of help from their parents. Kids this age go through big physical changes.


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