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Accountability
A
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Ad-Hoc Services
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Adequacy decision
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Analysis data model (ADaM)
A
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A
Appropriate safeguards
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Article 29 Working Party
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Biotechnology
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Term of the Day

Natural History Study

A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.

F

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA), an US administration, is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the nation's food supply, cosmetics, and products that emit radiation. The FDA has regulatory responsabilities, it enforces laws and regulations. It also produces guidance documents. It approves products, can organize recalls, market withdrawals, and safety alerts.