Business · 31/07/2012Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Premarket Approval Applications Review Process
The US Food and Drug Administration (FDA) has made available a draft guidance document outlining the criteria for accepting and filing Premarket Approval Applications (PMAs), aiming to standardize the agency's review decisions.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →