Definition
Approval Letter is FDA’s formal communication granting permission to manufacture and market a drug product in the United States. The letter confirms that the drug meets FDA’s standards for safety, efficacy, and manufacturing quality.
What Approval Means
FDA approval signifies:
- Demonstrated safety for intended use
- Proven efficacy for approved indications
- Benefits outweigh known risks
- Manufacturing meets quality standards
- Labeling is accurate and complete
Post-Approval Requirements
Approval often comes with ongoing obligations:
| Requirement | Description |
|---|---|
| Post-Marketing Studies | Phase 4 trials, safety registries |
| REMS | Risk Evaluation and Mitigation Strategy if required |
| Adverse Event Reporting | Ongoing safety surveillance |
| Annual Reports | Manufacturing and safety updates |
| Labeling Updates | Safety information as needed |
Why BD Teams Track Approvals
For business development professionals, FDA approvals are pivotal events:
- Deal Implication: Approval triggers milestone payments and shifts focus to commercial partnerships
- Due Diligence Focus: Review approved label for indication scope and any restrictions
- Opportunity Signal: Newly approved products may need commercial partners, especially for smaller companies