FDA Considers Altering Preclinical Testing Guidelines

'OPENING THE DOOR': FDA's Joseph Contrera claims the new testing guidelines will encourage innovation. The Food and Drug Administration (FDA) is considering a plan to revise a 25-year staple of preclinical pharmaceutical testing in the United States. Under the current procedure-criticized by some as lengthy and expensive-development of a new drug must include two-year bioassays conducted on two separate rodent species to determine whether it could cause cancer in humans. FDA recently closed

Thomas Durso
Oct 27, 1996

Joseph Contrera
'OPENING THE DOOR': FDA's Joseph Contrera claims the new testing guidelines will encourage innovation.
The Food and Drug Administration (FDA) is considering a plan to revise a 25-year staple of preclinical pharmaceutical testing in the United States. Under the current procedure-criticized by some as lengthy and expensive-development of a new drug must include two-year bioassays conducted on two separate rodent species to determine whether it could cause cancer in humans.

FDA recently closed the public-commentary period on a proposal, drawn up under the auspices of an international committee, that would replace that requirement with a more flexible guideline. While there is substantial praise for the plan, some observers argue that it relies on an unproved process that could fail to screen out dangerous drugs.

The FDA document, the "Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals," would give companies the optional alternative of limiting the two-year bioassay to just...

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