To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products.
This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Department of Health and Human Services (HHS) to review each regulation and guidance that applies to the dissemination by means of the Internet of information about medical products and to propose revisions to such regulations and guidance that:
facilitate meaningful use of the Internet by product sponsors for dissemination of truthful, non-misleading information about medical products; recognize that such sponsors may use the Internet to disseminate, in character-limited applications, truthful, introductory information about medical products and to provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and treat such hyperlinked information as if it appeared in such introductory information, for regulatory purposes. HHS is required, after providing notice and an opportunity for public comment, to: (1) publish final regulations and guidance addressing such matters within 18 months after publication of proposed regulations and guidance; and (2) review and update such regulations and guidance periodically.
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