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Pharmacogenomics (PGx), the use of genetic information to individualize drug therapy, is an immediate and important application of the Human Genome Project. The advent of PGx presents challenges to the U.S. Food and Drug Administration (FDA) in pursuing its mandate of protecting public health and safety. The authors conducted a review of academic, industry, and government literature using a technology diffusion framework to identify issues faced by the FDA relevant to the application of PGx. Two hundred and ten articles were reviewed. Key issues were categorized as rationale and structure for PGx regulation, regulation of PGx-based testing technologies, regulation of applications in clinical settings, regulation of data, and regulation of product life cycles. This review identifies issues faced by the FDA with respect to PGx, which the FDA is addressing through several initiatives. It also illustrates the complex issues involved in developing, implementing, and adopting new technologies.

Title from caption. ; Report year ends June 30. ; Mode of access: Internet. ; Continued in 1930 by: United States. Food and Drug Administration. Report of the Chief of the Food and Drug Administration.

"Contract No. FDA 223-75-2004." ; "SCOGS-93" ; Includes bibliographical references (p. 16-19). ; Mode of access: Internet. ; Dr. Nevin S. Scrimshaw;

Item 1016-A, 1016-B (microfiche). ; Distributed to some depository libraries in microfiche. ; Includes bibliographical references. ; Mode of access: Internet.

CIS Microfiche Accession Numbers: CIS 84 H401-36 ; Includes bibliographies. ; Microfiche. ; Mode of access: Internet.

"Public Law 102-282." ; "106 Stat. 149." ; "May 13, 1992, (H.R. 2454)." ; Shipping list no.: 92-333-P. ; Caption title. ; Mode of access: Internet.

Shipping list no.: 93-0522-P. ; Distributed to some depository libraries in microfiche. ; Includes bibliographical references. ; Mode of access: Internet.

"Civil Effects Test Group."--Cover. ; "Issuance date: May 1, 1959." ; "Project 38.2." ; "AEC Category: Biology and Medicine, Military Category: 28." ; "Operation Plumbbob Nevada Test Site May-October 1957." ; "WT-1497." ; Mode of access: Internet.

When do regulatory agencies expand, following the emergence of novel technologies? This article presents a verbal model that suggests that a regulator is most likely to announce that it has statutory authority to regulate a novel technology when its reputation is at stake. This is most likely to occur when (1) new information becomes available to the regulator regarding the seriousness of the anticipated harm of a novel technology, or (2) a rival regulator attempts to formalize its regulatory authority or fails to do so although officially required to. A historical-institutional analysis of the temporal process leading to jurisdictional claims by the U.S. Food and Drug Administration over gene therapy, laboratory-developed complex diagnostic tests, human tissue transplants, and human cloning supports the model's prediction. Adapted from the source document.

Considers FDA procedure for selecting sites for laboratory facilities. Focuses on the location of Laboratory No. 2 in Beltsville, Md. ; Record is based on bibliographic data in CIS US Congressional Committee Hearings Index. Reuse except for individual research requires license from Congressional Information Service, Inc. ; Indexed in CIS US Congressional Committee Hearings Index Part VIII ; Considers FDA procedure for selecting sites for laboratory facilities. Focuses on the location of Laboratory No. 2 in Beltsville, Md. ; Mode of access: Internet.

"Issuance Date: December 14, 1956"--Cover. ; "May 1956." ; "Operation Teapot - Nevada Test Site February - May 1955 ; program 32"--Cover. ; "WT-1222 ; AEC Category: Health and Biology ; Military Categories: 5-50 and 5-70"--Cover. ; Includes bibliographical reference (page 18). ; Mode of access: Internet.

Shipping list no.: 2014-0011-P (pt. 1A), 2013-0349-P (pt. 1B), 2014-0012-P (pt. 1C, 2), 2014-0020-P (pt. 3), 2014-0030-P (pt. 4), 2014-0021-P (pt. 5). ; part 1A. FY 2014 justifications of the budget estimates: Food and Drug Administration; Farm Credit Administration; Commodity Futures Trading Commission -- part 1B. FY 2014 justifications of the budget estimates: USDA explanatory notes, volume 1: Administration; Office of Inspector General; Office of General Counsel; Research, Education, and Economics; Marketing and Regulatory Programs; Food Safety -- part 1C. FY 2014 justifications of the budget estimates: USDA explanatory notes, volume 2: Farm and foreign agricultural services; natural resources and environment; Rural Development; food, nutrition, and consumer services; Foreign Agricultural Service; general provisions; expiring legislation -- part 2. USDA Food Safety and Inspection Service; USDA Food and Nutrition Service; USDA Inspector General -- part 3. Commodity Futures Trading Commission; Secretary of Agriculture; USDA research, education, and economics -- part 4. USDA marketing and regulatory programs; USDA rural development; USDA natural resources and environment -- part 5. USDA farm and foreign agricultural services; Food and Drug Administration. ; Mode of access: Internet. ; Description based on part 1B, volume 1.