Regulatory Contact

Definition 1

A person that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies regarding toxicity, protocol administration, and drug approval procedures. (NCI Thesaurus)

Definition 2

A person who is designated as the contact to be responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. (Food and Drug Administration)

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Regulatory Authority Jurisdiction Territory Code

A coded value specifying the geographical area or limits an authority has to make laws and enforce them.

Regulatory Authority Jurisdiction Authority Code

A coded value specifying the type of governance over which an authority has to make laws and enforce them.

Regulatory Authority Effective Date Range

The date and time span for when the regulatory authority is active.

Regulatory Authority

A geopolitical organization responsible for regulating products used in health care.

Regulatory Assessment Type Code

A coded value specifying the approval process used by the regulatory authority. EXAMPLE(S): FDA's Center for Devices and Radiological Health (CDRH) Process,FDA's…

Regulatory Assessment Reason Code

A coded value specifying the rationale for a regulatory designation.