FDA Policy/General

Covid-19 Related Guidances Listing Updated

David McFarland

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Federal Register notice: FDA is announcing the availability of FDA guidance documents related to the Covid-19 pandemic. The documents have been implemented without prior comment, but they remain subject to comment under the agency’s good guidance practices. They are:

  • Development of Abbreviated New Drug Applications During the COVID-19 Pandemic--Questions and Answers Guidance for Industry (April 2021)
  • Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry (April 2021)
  • Development of Abbreviated New Drug Applications During the COVID-19 Pandemic--Questions and Answers Guidance for Industry (April 2021
  • Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry (April 2021)

To view the notice, click here.

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