In a prepublication notice in the Federal Register published today (here), the FDA indicates that, since the COVID 19 pandemic has resulted in the declaration of a public health emergency by the President, and, through the regulatory authority given to the Secretary of Health and Human Services, the FDA will expedite important guidance on COVID 19 issues and will bypass the public comment period normally required by the Agency’s Good Guidance Practices. This process will allow the FDA to disseminate its thinking and guidance to industry and health care providers as quickly as possible. The FDA will, of course, take into consideration any comments submitted by the public and may revise those guidances issued under this plan, as deemed appropriate.
The Agency notes that “[g]uidance documents related to COVID-19 will be accessible on the internet from the FDA webpage entitled “Coronavirus Disease 2019 (COVID-19),” available here. In addition, the FDA also advises that it will not be publishing a Notice of Availability (NOA) in the Federal Register each time a guidance issues, but rather will issues a consolidated NOA at regular intervals. New guidance documents can be accessed at any time from the above link.
The Agency will also establish a docket for each FDA Center that will be a repository for each guidance. The FDA make the docket numbers available in the prepublication notice (see the link in the first paragraph above).
Stay safe out there and keep tuned to our blog post for the most current information.