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Once FDA makes this determination, it must give the responsible party an opportunity to voluntarily recall the product, but if the responsible party refuses to or does not voluntarily recall, FDA has the authority to initiate a mandatory recall by issuing a mandatory recall order

A pooled exploratory analysis of the SURPASS 1-4 trials provided a deeper characterization of this phenomenon

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Medication may be prescribed only if deemed appropriate

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The common clinical manifestations of FMRD typically present as infantile encephalopathies in the neonatal period and early stages of life, such as poor feeding, growth retardation, hypotonia, lethargy, and epileptic seizures, etc