'OPENING THE DOOR': FDA's Joseph Contrera claims the new testing guidelines will encourage innovation.
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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