Patients should be evaluated within three weeks.

For many products, the new labeling included information for use in neonates and children younger than 2 years.

Lowering toxic elements in foods eaten by infants, children a priority for FDA.

Pediatric providers are encouraged to share the resources on social media and with patients, families and colleagues.

Biosimilars can increase access to lifesaving medications and potentially lower health care costs through competition.

Listening sessions are among the ways the FDA includes the voices of patient communities in medical product development and the regulatory process, particularly communities that have been historically underrepresented.

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

The studies enrolled 410 patients ages 10 to 17 years with inadequately controlled type 2 diabetes; two studies included patients on metformin therapy.

The Cognoa ASD Diagnosis Aid should be used in conjunction with patient history and clinical evidence and not as a stand-alone device.

The Cognoa ASD Diagnosis Aid should be used in conjunction with patient history and clinical evidence and not as a stand-alone device.

The FDA also approved a new oral pellets dosage form of the direct thrombin inhibitor for children who cannot swallow capsules.

Ongoing projects include establishing data standards for neonatal studies, defining normal hemodynamic parameters for preterm and term neonates, developing a state-of-the art white paper to guide retinopathy of prematurity studies, and publishing a protocol to guide trials of neonatal seizure therapies.

During the workshop on long-term safety studies, experts discussed elements of design and implementation strategies.

The Food and Drug Administration (FDA) recognizes the need for safe and effective therapies for pediatric patients with heart failure.

The new rule allows pediatric medical cribs with drop-side or latched rails and medical bassinets to be used in a home, child care center or other facility if prescribed by a health care provider for a particular patient.