Title 38--United States code: Veterans' benefits. : January 3, 1973.

"Soldiers' and sailors' civil relief act of 1940, as amended": p. 311-330.

FDA consumer nutrition knowledge survey : a nationwide study of food shopper's knowledge, beliefs, attitudes, and reported behavior regarding food and nutrition /

Includes bibliographical references.

Service and regulatory announcements.

Some numbers issued in revised editions.

Index-catalogue of medical and veterinary zoology.

Description based on: 22, pt. 1, published in Dec. 1978.

Directory of biosphere reserves in the United States /

Mode of access: Internet.

Proceedings of the Southern Pasture and Forage Crop Improvement Conference.

Latest issue consulted: 42nd (Apr. 15-16, 1986).

Notices of Judgment under the Federal Food, Drug, and Cosmetic Act. Drugs and Devices

Mode of access: Internet.

Service and Regulatory Announcements. Caustic Poison

Mode of access: Internet.

Manual of meat inspection procedures of the United States Department of Agriculture.

Mode of access: Internet.

Annual conference report on cotton-insect research and control.

Mode of access: Internet.

Process inventory and pollution prevention overview for the citrus industry

Florida citrus represents approximately 70 percent of the industry production in the United States; therefore, any associated agricultural and industrial contamination is of concern and a focus of attention. The use of synthetic organic chemicals has become a farmer's necessity in order to supply consumers with high quality products, free of pest damage. However, industrial citrus wastes and chemical residual levels worry not only government agencies but also consumers since they indicate a serious habitat risk. This study assesses citrus industrial processes and the paths that chemical substances follow from the time the citrus seed is planted until consumers get a final product as either fresh fruit or processed product. The study is built on information from United States Environmental Protection Agency (US EPA) manuals, Dade County Environmental Resources Management (DERM) inspection records, United States Food and Drug Administration (US FDA) regulations, Florida standards, journal publications, and research reports. Pollution prevention (P2 or prevention-of-pollution) alternatives are identified; alternatives are proposed, evaluated, and included. Strategies are described and pollution prevention opportunities proposed to minimize citrus wastes generation, chemical residuals in products, their environmental impact and health risk aspects while maximizing product quality.

United States Soldiers' & Airmen's Home : [Washington D.C.].

"6 January 1988."

Patents for humanity

This article evaluates two policy initiatives by the United States Government to address access to essential medicines -- Priority Review vouchers and “Patents for Humanity." Such proposals are aimed at speeding up the regulatory review of inventions with humanitarian uses and applications by the United States Food and Drug Administration, and the United States Patent and Trademark Office. It is argued that such measures fall short of international standards and norms established by the World Intellectual Property Organization Development Agenda 2007; the World Trade Organization’s Doha Declaration on the TRIPS Agreement and Public Health 2001 and the WTO General Council Decision of August 30, 2003; and the World Health Organization’s declarations on intellectual property and public health. This article concludes that there is a need for broader patent law reform in the United States to address matters of patent law and public health. Moreover, there is a need to experiment with other, more promising alternative models of research and development -- such as medical innovation prizes, a Health Impact Fund, the Medicines Patent Pool, and Open Source Drug Discovery.

Returns to R&D on new drug introductions in the 1980s.

This study finds that the mean IRR for 1980-84 U.S. new drug introductions is 11.1%, and the mean NPV is 22 million (1990 dollars). The distribution of returns is highly skewed. The results are robust to plausible changes in the baseline assumptions. Our work is also compared with a 1993 study by the OTA. Despite some important differences in assumptions, both studies imply that returns for the average NCE are within one percentage point of the industry's cost of capital. This is much less than what is typically observed in analyses based on accounting data.

Economic return of clinical trials performed under the pediatric exclusivity program.

CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007. OBJECTIVE: To quantify the economic return to industry for completing pediatric exclusivity trials. DESIGN AND SETTING: A cohort study of programs conducted for pediatric exclusivity. Nine drugs that were granted pediatric exclusivity were selected. From the final study reports submitted to the FDA (2002-2004), key elements of the clinical trial design and study operations were obtained, and the cost of performing each study was estimated and converted into estimates of after-tax cash outflows. Three-year market sales were obtained and converted into estimates of after-tax cash inflows based on 6 months of additional market protection. Net economic return (cash inflows minus outflows) and net return-to-costs ratio (net economic return divided by cash outflows) for each product were then calculated. MAIN OUTCOME MEASURES: Net economic return and net return-to-cost ratio. RESULTS: The indications studied reflect a broad representation of the program: asthma, tumors, attention-deficit/hyperactivity disorder, hypertension, depression/generalized anxiety disorder, diabetes mellitus, gastroesophageal reflux, bacterial infection, and bone mineralization. The distribution of net economic return for 6 months of exclusivity varied substantially among products (net economic return ranged from -$8.9 million to $507.9 million and net return-to-cost ratio ranged from -0.68 to 73.63). CONCLUSIONS: The economic return for pediatric exclusivity is variable. As an incentive to complete much-needed clinical trials in children, pediatric exclusivity can generate lucrative returns or produce more modest returns on investment.