Drugs

FDA Advancing Treatments for Children

Three FDA officials say the agency is continuing to work with stakeholders to advance treatment options for children. Writing in an FDA Voice post, the three say FDA is working to:

improve the timeliness of pediatric medical product development;
engage patients and their families in clinical research; and
collaborate with international regulators.

“FDA is committed to taking steps in these three areas to promote clinical research for children, particularly for pediatric populations that face unique challenges such as newborns, children with rare diseases, and children with cancer,” the post concludes. “The agency’s continued collaboration with patients and their families, industry, international regulators, and the pediatric clinical research community will help shape the future of pediatric medical product development.”

The post notes that FDA recently hit a milestone of 1,000 medicines that include evidence-based pediatric information in the labeling. Some of the medicines have been approved for children, it says, and others have been updated to include additional information to help healthcare professionals make informed decisions when treating children. The medicines include those to treat health conditions such as certain infectious diseases, cancer, and neurologic diseases that previously had no approved treatments for children.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome