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Zdrowie i gospodarka · 16/12/2019

FDA Repeals Regulation Requiring New Drug Application for Sterilized Drugs

The US Food and Drug Administration (FDA) is issuing a final rule repealing a regulation that required an FDA-approved new drug application for drugs sterilized by irradiation, allowing over-the-counter drugs to be marketed without approval, as the regulation is deemed out of date and unnecessary.

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