The US Food and Drug Administration (FDA) is seeking comment on whether it should issue more guidances as final for immediate implementation without first submitting the undergoing the documents to the formal notice and comment period. The agency said that doing so would enable it to keep pace with “rapid scientific developments” and use limited resources more efficiently.
This input was requested in a notice published in the Federal Register earlier this week as part of its Good Guidance Practices and was accompanied by a 27-page report outlining the agency’s experience and proposed actions. FDA said that the COVID–19 Public Health Emergency (PHE) “pushed us to consider innovative approaches to streamline guidance issuance and regulatory submissions to reach a broad audience in an expedited manner.”…
