Category: F

Frequency of ADRs

The following are standard ADR frequency categories where the denominator must be defined to provide context: Very common: > 10% Common: [1%, 10%] Uncommon: [0.1%, 1%] Rare:

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File Tag

An identifier chosen from a defined list that is applied to an element in a Study Tagging File that identifies the type of the file.

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FDA 356h

FDA form: Application to Market a New or Abbreviated New Drug or Biologic for Human Use

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FDA 2253

FDA Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use form submitted to the FDA with all promotional material sequences.

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FDA 1571

FDA Investigational New Drug application form. The cover sheet for a US Investigational New Drug (IND) Application, which reports the phase of a proposed study,

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