The Federal Food, Drug, and Cosmetic Act and Public Health Service Act
require that sponsors of FDA-regulated
products submit evidence of their product’s
safety in research and/or marketing
applications. These products include food and
color additives, animal drugs, human drugs and
biological products, human medical devices,
diagnostic products, and electronic products.
FDA uses the data to answer questions
regarding:
- The toxicity profile of the test article.
- The observed no adverse effect
dose level in
the test system.
The risks associated with clinical
studies involving humans or animals.
The potential teratogenic, carcinogenic,
or other adverse effects of the test article.
The level of use that can be approved.
The following
resources are provided to help investigators,
sponsors, and contract research organizations
who conduct nonclinical studies on investigational new drugs
to comply with U.S.
law and regulations covering good laboratory practice (GLP).
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