Chris150
Oct 2, 4:13 PM
$CLNN Just FYI about NDA:
The eCTD (Electronic Common Technical Document) is the mandatory digital format used by the U.S. Food and Drug Administration (FDA) for submitting an NDA (New Drug Application), along with BLAs, ANDAs, commercial INDs, and master files.
• Key Requirements & Structure: Mandatory Format: Paper or PDF-only submissions are no longer accepted for original NDAs. All filings must go through the FDA Electronic Submissions Gateway (ESG).
• Five-Module Structure: The dossier is organized into five standard parts:
• Module 1: Region-specific administrative information and prescribing data (e.g., FDA Form 356h, cover letters).
• Module 2: Common Technical Document summaries (Quality Overall Summary, Nonclinical Overview/Summary, Clinical Overview/Summary).
• Module 3: Quality (Chemistry, Manufacturing, and Controls - CMC).
• Module 4: Nonclinical study reports (pharmacology, pharmacokinetics, toxicology).
• Module 5: Clinical study reports and efficacy/safety data.
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