Zdrowie i gospodarka · 01/04/2020

FDA Issues Guidance for Industry on Notifying of Manufacturing Discontinuance Due to COVID-19 Pandemic

The Food and Drug Administration (FDA) has released a guidance document to help applicants and manufacturers notify the agency of permanent discontinuance or interruption in manufacturing under Section 506C of the Federal Food, Drug, and Cosmetic Act, amid concerns of supply chain disruptions and shortages of drug and biological products in the US, triggered by the COVID-19 pandemic.