Federal register
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The Food and Drug Administration (FDA) is publishing a guidance entitled "E5 Ethnic Factors in the Acceptability of Foreign Clinical Data". The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance recommends regulatory and development strategies to permit clinical data collected in one region to be used for the support of drug and biologic registrations in another region while allowing for the influence of ethnic factors.
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The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the National Institutes of Health's National Institute of Dental Research (NIDR) and three of FDA's line organizations: the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research. The purpose of the MOU is to facilitate interactions between NIDR and FDA regarding improvements in the quality and relevance of preclinical and clinical research, which is directed to the development of products for use in oral healthcare.
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The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.
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The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to repeal FDA's regulations governing certification of drugs containing insulin and make conforming amendments to other sections of the agency's regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act.