The FDA has announced an expedited process for making COVID-19-related guidance documents available to the public (Federal Register, 25-March-2020). The intent is to “allow the agency to rapidly disseminate essential agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders,” the FDA stated in its Federal Register announcement. Note: The process is specific to FDA guidance documents related to the COVID-19 public health emergency; it does not extend to other FDA guidance documents.
- Because of “the need to act quickly and efficiently,” the FDA “anticipates” it will issue COVID-19 related guidance documents without prior public comment.
- The agency will still “solicit comment, review all comments received, and revise the guidance documents as appropriate,” but not prior to publication. Each guidance document will note the relevant docket number(s) for submitting comments.
- Guidance documents related to COVID-19 will be accessible online on an FDA webpage: “Coronavirus Disease 2019 (COVID-19).” They are also accessible on the FDA’s “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders” page, and from: “Search for FDA Guidance Documents.”
- Rather than a separate Notice of Availability (NOA) for each guidance document, the FDA periodically will publish a consolidated NOA for the various guidance documents related to COVID-19. The consolidated NOA will include instructions for submitting comments.
- The FDA intends to establish a separate docket for each of the agency centers or offices that may issue guidance documents related to COVID-19. Table 1 lists the FDA centers/offices and their docket numbers.
|Docket title for each FDA center or office||Docket number|
|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|
Table 1. Dockets for public comments on FDA COVID-19 guidance documents
21 CFR 10.115 , Good guidance practices, describes the typical processes the FDA follows when developing and issuing guidance documents.
The FDA published the agency’s first COVID-19-specific guidance on February 29, then issued an update to it on March 16: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. It took immediate effect. [The agency subsequently held a public workshop on the guidance to engage with clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.] The FDA issued 13 pandemic-related guidance documents between March 14 and March 26 on topics ranging from clinical trial conduct and adverse event reporting to ventilators and alcohol-based hand sanitizers.
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