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Imported item 10
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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

N

Imported item 15

A new drug application (NDA) is a submission asking the US Food and Drug Administration to approve a medicine for marketing. It brings together evidence about safety, effectiveness, manufacturing and proposed labelling. An NDA is a marketing application, not permission to begin a clinical trial.

Key Takeaways

  • An NDA supports an FDA marketing decision, whereas an IND supports the investigation of an unapproved drug.
  • A biologics licence application is a separate marketing route, not a stage that automatically follows an NDA.
  • Submission planning should distinguish confidential regulatory records from documents prepared for public disclosure.

How Does an NDA Fit into Development?

ElementMeaning
INDInvestigational pathway for clinical development
NDAMarketing application for a drug
BLAMarketing application for a biological product

The FDA evaluates whether the evidence supports the proposed use, whether the product information is appropriate and whether manufacturing controls are adequate. Nonclinical and clinical findings generated during development contribute to that assessment. The corresponding European concept is a marketing authorisation application (MAA), although the procedure and dossier requirements are not interchangeable. Plan the submission route for the actual product rather than treating IND, NDA and BLA as a single universal sequence.

Primary guidance: FDA NDA overview; FDA BLA overview; EMA marketing authorisation application.

Why It Matters for Data Protection

For a hypothetical biotech preparing an NDA, we recommend inventorying the patient-level datasets, narratives and appendices before transfer to the submission team. Identify who can access each version, which vendors handle the package and what information must remain traceable to source records. Do not use the public-disclosure copy as a substitute for the regulatory master. A practical handover should name an owner for redaction, access review and retained evidence, with a clear process for responding to later regulator questions.

Frequently Asked Questions

Is an NDA the same as an IND?

No. An IND concerns clinical investigation; an NDA seeks marketing approval.

Does every medicine use an NDA?

No. Biological products may require a BLA, and other application pathways exist.

Does NDA mean confidentiality agreement?

In another context, yes. In drug development it means new drug application.

Related reading: investigational new drug ind; food and drug administration fda.

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Updated: 27 October 2026