New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for Comments
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA, Agency, or we) is seeking public comments on the "New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation." The purpose is to seek public comments/feedback on the Integrated Review documentation generated by the Integrated Assessment of Marketing Applications for new drug products developed as part of the New Drugs Regulatory Program Modernization. The Agency hopes to receive public feedback on how this Integrated Review documentation can continue supporting our stakeholders' needs.
Abstract as published in the Federal Register.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account