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The company will have to keep a registry of any reported issues after exposure during pregnancy, including "major and minor congenital malformations, spontaneous abortions, stillbirths, elective terminations, small for gestational age, preterm birth and any other adverse pregnancy outcomes," according to the FDAs letter

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Knudsen reconoce que la firma no ser capaz de satisfacer la demanda "a corto plazo", pero aade que se est invirtiendo mucho para expandir la capacidad fabricante