Zdrowie i gospodarka · 08/02/2008

FDA Announces Enforcement Action Against Unapproved Colchicine for Injection Products

The FDA is taking enforcement action against unapproved colchicine for injection products due to their potential for serious adverse events and narrow margin of safety, requiring manufacturers to obtain FDA approval for new drug applications.

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

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