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NIH Funded Pediatric Labeling Changes for drugs studied under the 409i process
Section 409i of BPCA requires NIH and FDA to prioritize therapeutic areas in critical need of pediatric research.
Read MoreProject Orbis
Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners
Read MoreNotices of Updates
Webpage providing notices of updates to FDA's STIC webpages for antibacterial and antifungal drugs.
Read MorePediatric Low-Grade Glioma: Defining the Disease and Its Long-Term Impact
(MedPage Today) -- MedPage Today brought together three expert leaders for a virtual roundtable discussion on pediatric low-grade glioma.
Read MoreBiosimilar Product Information
This page includes a chart of the approved biosimilar and interchangeable products.
Read MoreHere's What Doctors Should Know About Slushies and Kids
(MedPage Today) -- Last year, alarming news reports detailed the hospitalizations of at least two children in the U.K. who developed glycerol intoxication shortly after drinking frozen slushies.
Read MoreNovo Nordisk follows Eli Lilly with its own ‘triple-G’ drug
Novo Nordisk said it's licensed a new obesity drug from The United Laboratories, a Chinese drugmaker.
Read MoreMigraines made life feel unlivable. It took years to find a doctor who believed me
Experts said my headaches and vertigo were just anxiety.
Read MoreAntibacterial Susceptibility Test Interpretive Criteria
Antibacterial Susceptibility Test Interpretive Criteria
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