Input from interested parties will be incorporated into the FDA’s report to Congress on the implementation and impact of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act.

One in four U.S. children suffers from allergic diseases, and more than 6% of children are diagnosed with asthma, according to the Centers for Disease Control and Prevention.

Delta-8 THC is an intoxicating substance found in low amounts in cannabis plants and likely is produced by synthetic methods.

The Food and Drug Administration organizes public workshops to analyze issues that confound the development and use of pediatric therapeutics and to discuss and advance potential solutions.

The One Health initiative emphasizes the need for various disciplines and sectors to come together to promote human, animal and environmental health, recognizing that the health of children and adults is tied closely to the health of animals and our shared environment.

While it typically takes six to 10 years for a drug approved for adults to receive pediatric labeling, remdesivir was approved for use in pediatric patients, including neonates, about three years after approval for use in adults and adolescents.

The FDA is using a variety of surveillance tools to monitor the evolving tobacco product landscape and identify emerging threats to public health.

Many of the labeling changes represent a new approval by the Food and Drug Administration for an indication in children.

Families can use the test results to take action for their child’s health or seek their pediatrician’s advice .

The FDA’s Bad Ad Program seeks to raise awareness in the medical community of potentially false or misleading prescription drug promotion.

The Modernization of Cosmetics Regulation Act of 2022 will require companies and individuals who manufacture or market cosmetics to substantiate the safety of their products and report serious adverse events to the FDA, among other requirements.

Health care providers should report adverse events and medication errors associated with the monoclonal antibody nirsevimab-alip, recently approved to protect infants and certain high-risk toddlers from respiratory syncytial virus (RSV).

Linzess (linaclotide) capsules is a guanylate cyclase-C agonist that works by increasing intestinal fluid and accelerating intestinal transit.

The FDA continues to warn patients, caregivers and health care professionals about the dangers of accidental opioid overdose in children.

Sildenafil is indicated to improve exercise ability and pulmonary hemodynamics thought to underly improvements in exercise in patients too young to perform standard exercise testing.

A medical product’s potential adverse effects on a neonate’s developing nervous system may not manifest clinically until well after exposure.

More than 2.5 million U.S. youths reported current use of e-cigarettes, according to 2022 data.

Many, but not all, labeling changes represent a new Food and Drug Administration approval for an indication in children.

Since the early 1950s, the FDA has approved more than 50 drugs with over 70 indications for the treatment of pediatric cancers.

The guidance describes methods for measuring and recording growth and evaluating pubertal development to assess safety for pediatric participants in clinical trials.