Building FDA submissions like a solid house requires early collaboration, proactive planning, and a clear regulatory story.

According to the FDA, the web-based forms include Forms FDA 4057, 4057a, 3965 and 3965a. Industry stakeholders with active ...

The forms, part of the agency’s upgraded CTP Portal Next Generation, let applicants create, validate and submit premarket ...

The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency ...

The late-stage biopharma company reported that the FDA agreed its existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support NDA submission and ...

The road to FDA clearance for medical devices may change radically in the next year. Last summer, initial discussion began around implementing a pre-certification program for medical device companies, ...