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Zdrowie i gospodarka · 26/03/2024

FDA Clears Path for ISUPREL Injection to be Approved via Abbreviated New Drug Application Process

The US Food and Drug Administration has determined that ISUPREL injection, 0.2 mg/mL, was not withdrawn from sale due to safety or effectiveness concerns, paving the way for potential approval of abbreviated new drug applications.

Source: Federal Register — Food and Drug AdministrationOpen original release →