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Zdrowie i gospodarka · 07/11/2000

FDA Amends Biological Products Regulation to Require Manufacturers to Report Deviations in Manufacturing

The FDA is updating its regulations to require licensed manufacturers of biological products to report any errors or accidents in manufacturing that may impact product safety, purity, or potency, with a 45-day reporting period.

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