FDA to Implement All COVID-19-Related Guidance Immediately, Without Public Comment

Regulatory NewsRegulatory News | 20 March 2020 |  By 

In light of the need to act quickly and efficiently to respond to the COVID-19 public health emergency, the US Food and Drug Administration (FDA) on Friday said that it anticipates that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidance documents.

Although COVID-19-related guidance documents will be immediately implemented without prior public comment, FDA said it will still solicit comment, review all comments received and revise the guidance documents as appropriate.

In addition, rather than publishing a separate Notice of Availability (NOA) for each COVID-19-related guidance document, FDA said it intends to publish periodically a consolidated NOA.

“This periodic NOA will announce the availability of all the COVID-19-related guidance documents that issued during the relevant period. The consolidated NOA will provide instructions to the public on submitting comments on COVID-19-related guidance documents, including the docket number(s) associated with each guidance document, information on how to view the dockets, and instructions for persons interested in obtaining a copy of a COVID-19-related guidance document," the Federal Register notice said.

FDA intends to establish one docket for each Center or Office that may issue COVID-19-related guidance. The docket numbers associated with each Center or Office that may issue COVID-19-related guidance documents are as follows:
  • Center for Drug Evaluation and Research (CDER) COVID-19, FDA-2020-D-1136
  • Center for Biologics Evaluation and Research (CBER) COVID-19, FDA-2020-D-1137
  • Center for Devices and Radiological Health (CDRH) COVID-19, FDA-2020-D-1138
  • Center for Food Safety and Applied Nutrition (CFSAN) COVID-19, FDA-2020-D-1139
  • Center for Veterinary Medicine (CVM) COVID-19, FDA-2020-D-1140
  • Center for Tobacco Products (CTP) COVID-19, FDA-2020-D-1141
  • Office of the Commissioner (OC) COVID-19, FDA-2020-D-1142
  • Office of Regulatory Affairs (ORA) COVID-19, FDA-2020-D-1143

Federal Register Notice

Coronavirus Disease 2019 (COVID-19)


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