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PEDIATRIC PAGE - accessdata fda 2025

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The document pertains to the New Drug Application (NDA) 50-821 for Cefepime for Injection USP and Dextrose Injection USP in a Duplex container, submitted by B. Braun Medical, Inc. It includes administrative details, pediatric study requirements, and correspondence regarding the application process with the FDA. The document outlines indications for use, regulatory considerations, and responses to pediatric study requirements under the Pediatric Research Equity Act (PREA). It also discusses waivers and deferrals related to pediatric studies and provides timelines for submission and review.

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What is the pediatric research equity act?

The Pediatric Research Equity Act amends the federal Food, Drug, and Cosmetic Act to authorize the FDA to require pediatric studies of drugs or biologics when other approaches are insufficient to ensure that the products are safe and effective for use in children.

What are the criteria for FDA pediatric waiver?

FDA may grant a waiver from PREA requirements to study a medicine in children when (1) necessary studies are impossible or highly impracticable; (2) there is evidence strongly suggesting that the product would be ineffective or unsafe in all pediatric age groups; or (3) the product does not represent a meaningful

How old is the pediatric population?

If only patients who have not yet turned 18 years old are included, the study can be called pediatric and the terms child or children can be used throughout and in keywords.

What is the FDA for pediatric patients?

The FDA is committed to assuring pediatric patients have access to safe and effective medical products. Through federal laws, pediatric research, and child-focused initiatives, the FDA supports the development and availability of drugs, biologics, and medical devices for children.

How does the FDA define pediatric?

The Federal Food, Drug, and Cosmetic Act (FDC Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment. Pediatric subpopulations are further categorized as follows: Neonates - from birth through the first 28 days of life. Infants - 29 days to less than 2 years.

What is the FDA pediatric labeling information database?

The FDA created the Pediatric Labeling Information Database to make it easier for parents and health care professionals to find information on pediatric medications. The FDA also provides a safety reporting page with information on products that have been tied to safety problems that specifically relate to children.

What is the FDA prea for pediatrics?

PREA gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for the product.

What age does FDA consider pediatric?

The Federal Food, Drug, and Cosmetic Act (FDC Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment.

PEDIATRIC PAGE - accessdata fda 2025

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