Αποτελέσματα Αναζήτησης
These specifications are for creating documents in Portable Document Format (PDF) for submission to CDER or CBER, that align with ICH M2 recommendations1 and that are in a format that the ...
Conduct Review of New Drug Application (NDA) or Biologics License Application (BLA) The review process takes place in six major steps. Each step will be described in detail later in this...
What file formats is FDA able to access and review? FDA can receive, process, review, and archive many commonly used file types, also referred to as file formats.
ELECTRONIC SUBMISSION GUIDANCE. “eCTD Guidance” - Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. Updated February 2020 (Revision 7) Type III DMF added to exemption section.
This document provides guidance to industry and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on good review management principles and practices (GRMPs) for the conduct of the first cycle
• Generate compliant, submission-ready PDF renditions for multiple Health authorities before publishing eCTD leafs • Fix and validate PDFs against a range of Health authority requirements • Convert and enrich a range of different file formats from multiple content repositories
Sponsors need to understand the differences precisely and consider efficient processes to meet requirements of each health authority (HA). This e-Poster illustrates about e-Submissions and focus on key differences between e-submission requirements for the FDA and PMDA.
