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.

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.

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

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.

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

Although Tzield does not prevent or cure T1D, treatment can delay the need for exogenous insulin therapy and its associated risks and intensive regimen.

Some children may be at increased risk for severe disease.

A single generic competitor can lead to price reductions of 30%, while five competing generics are associated with price drops of nearly 85%.

Prior to passage of the first law incentivizing pediatric studies in 1997, more than 80% of approved drugs had no pediatric-specific labeling information.

The FDA identified six cases supporting a plausible association between GnRH agonist use and pseudotumor cerebri. Five were undergoing treatment for central precocious puberty and one for transgender care.

Officials provides updates on resources to aid schools and available therapeutics designed to treat COVID-19 patients.

Both products contain two direct-acting antiviral drugs that provide a complete regimen for treatment of chronic hepatitis C virus infection.

Medication nonadherence is a problem across pediatric chronic diseases, even those that can be life-threatening.

AAP resource provides answers on use of outpatient monoclonal antibody therapy for COVID-19.

Recommendations for use of treatments in children are extrapolated from adult data. Clinical trials are needed to demonstrate benefit in pediatric patients.