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Revised IOL Guidance Requires 100-Patient Study For Some Design Changes

This article was originally published in The Gray Sheet

Executive Summary

"Level B" modifications to intraocular lenses (IOLs) would require a 100-subject confirmatory study in addition to preclinical data, under FDA's draft "Intraocular Lens Guidance Document" posted July 16 on the agency's website.

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Intraocular lens guidance

Clinical studies comparing an investigational IOL to a historical control should have a minimum of 300 subjects, while certain modifications to approved devices would require 100 subjects (1"The Gray Sheet," July 26, p. 6), according to the agency's draft "Intraocular Lens Guidance." Comments are due by Jan. 12, 2000

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.




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