TABLE 4–1 Sources of Information for Key Factors and Modifiersa

Key Factors and Modifiers

Screening/Flagging

Priority Setting

Monograph/Critical Evaluation

Key factors

Human data

Serious adverse events:

MedWatch

Poison Control Center

Cursory search in scientific and medical literature including IBIDS, Medline, Toxline

Letters to the Center for Food Safety and Applied Nutrition

Sources listed at left

Secondary reviews

Sources listed at left

All available sources, including:

Published case reports—available through MedLine or other literature

Unpublished safety information requested from published clinical studies

Unpublished safety information requested from manufacturers

Prepublication safety information requested from clinical trials

Discovery materials from tort litigation

Animal data

Consider under “Other Concerns”

Literature searches (e.g., IBIDS, MedLine, Toxline, Embase)

Database searches (e.g., NAPRALERT, Poisindex, Naurac)

Secondary reviewsb

Sources listed at left

Data voluntarily provided by industry

Data provided by animal poison control centersc

Biological activity of structurally related or taxonomically related substances

Consider under “Other Concerns”

Poisonous plants (Kingsbury, 1964)

NAPRALERT

Sources listed at left

Data voluntarily provided by industry

In vitro data

Consider under “Other Concerns”

Literature searches (e.g., IBIDS, MedLine, Toxline, Embase)

Database searches (e.g., NAPRALERT, Poisindex, Naurac)

Secondary reviews

Sources listed at left

Data voluntarily provided by industry



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