Annual Report(AR)
A yearly report submitted to FDA summarizing changes and updates to an approved drug application.
Usage Examples
- The annual report included updated distribution data.
- Manufacturing site changes were documented in the annual report.
- The AR was submitted within the 60-day window.
What is AR?
Annual Reports are required for approved NDAs, ANDAs, and BLAs under 21 CFR 314.81(b)(2). They summarize information about the drug product that FDA should be informed of but that doesn't require a supplement or other expedited reporting.
Content includes distribution data, labeling, chemistry changes, nonclinical studies, clinical studies, changes in formula or specifications, advertisements, and IND safety reports. The report covers the period since the last annual report.
Annual reports are due within 60 days of the anniversary of the approval date. They're distinct from expedited supplements required for certain changes.
Regulatory Context
This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 314 81.
When This Matters
- The annual report included updated distribution data.
- Manufacturing site changes were documented in the annual report.
- The AR was submitted within the 60-day window.
Common Mistakes
- Treating submission readiness as a formatting-only check without lifecycle validation.
- Using outdated guidance references across modules and summaries.
- Missing cross-functional review between RA, CMC, and quality before submission.
Related Regulations
Frequently Asked Questions
Annual reports contain minor changes not requiring supplements, distribution data, and updated labeling. Significant changes like new indications, formulation changes, or manufacturing site changes require prior approval or changes-being-effected supplements.
Within 60 days of the anniversary of the original approval date. Some sponsors align fiscal year reporting, but the regulatory due date is based on approval anniversary.
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Sources & References
