Introduction of FDA guidance for dealing with drug shortage in public health emergency

ABSTRACT

In light of the Coronavirus Disease 2019 (COVID-19) public health emergency in America, FDA issued Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry in March 2020. This guidance aimed to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products, so as to ensure the stability of the medical product supply chain in America. This guidance was still useful for perfecting interruption in manufacturing reporting system of China.