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Authorized Generic Pharmaceuticals: Effects on Innovation

Description: The practice of “authorized generics” has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An “authorized generic”–sometimes termed a “branded,” “flanking,” or “pseudo” generic–is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favorable to consumers, aut… more
Date: August 8, 2006
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department
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Avian Flu Pandemic: Potential Impact of Trade Disruptions

Description: Concerns about potential disruptions in U.S. trade flows due to a global health or security crisis are not new. The possibility of an avian flu pandemic with consequences for global trade is a concern that has received attention recently, although some experts believe there is little cause for alarm. This report considers possible trade disruptions, including possible impacts on trade between the United States and countries and regions that have reported avian influenza infections.
Date: May 8, 2008
Creator: Langton, Danielle
Partner: UNT Libraries Government Documents Department
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Avian Influenza: Agricultural Issues

Description: Since the fall of 2003, a strain of highly pathogenic avian influenza (H5N1) has spread throughout Asia, infecting mostly poultry but also a limited number of humans. The virus reached Europe in 2005, and the Middle East and Africa in 2006. Avian flu is highly contagious in domestic poultry. Strict biosecurity measures are practiced by commercial poultry farms and encouraged by governments. The economic effects of avian flu outbreaks can be significant, especially given international trade rest… more
Date: May 10, 2006
Creator: Monke, Jim
Partner: UNT Libraries Government Documents Department
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Background and Legal Issues Related to Stem Cell Research

Description: This report discusses issues regarding stem cell research. With certain restrictions, the President has announced that federal funds may be used to conduct research on human embryonic stem cells. Federal research is limited to "the more than 60" existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds will be used for the deri… more
Date: October 26, 2004
Creator: Shimabukuro, Jon O.
Partner: UNT Libraries Government Documents Department
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Background and Legal Issues Related to Stem Cell Research

Description: In August 2001, President Bush announced that federal funds, with certain restrictions, may be used to conduct research on human embryonic stem cells. This report explains the limitations on this research, as well as corresponding and related legislation to the issue of embryonic stem cell research, including the Stem Cell Research Enhancement Act of 2005.
Date: July 13, 2006
Creator: Shimabukuro, Jon O.
Partner: UNT Libraries Government Documents Department
open access

Background and Legal Issues Related to Stem Cell Research

Description: In August 2001, President Bush announced that federal funds, with certain restrictions, may be used to conduct research on human embryonic stem cells. Federal research is limited to “the more than 60” existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds may be used for the derivation or use of stem cell lines derived from … more
Date: June 12, 2002
Creator: Duffy, Diane T
Partner: UNT Libraries Government Documents Department
open access

Background and Legal Issues Related to Stem Cell Research

Description: In August 2001, President Bush announced that federal funds, with certain restrictions, may be used to conduct research on human embryonic stem cells. Federal research is limited to “the more than 60” existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds may be used for the derivation or use of stem cell lines derived from … more
Date: July 13, 2006
Creator: Shimabukuro, Jon O.
Partner: UNT Libraries Government Documents Department
open access

Background and Legal Issues Related to Stem Cell Research

Description: In August 2001, President Bush announced that federal funds, with certain restrictions, may be used to conduct research on human embryonic stem cells. Federal research is limited to “the more than 60” existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds may be used for the derivation or use of stem cell lines derived from … more
Date: July 13, 2006
Creator: Shimabukuro, Jon O.
Partner: UNT Libraries Government Documents Department
open access

Beneficiary Information and Decision Supports for the Medicare-Endorsed Prescription Drug Discount Card

Description: On December 8, 2003 the President signed into law the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA, P.L. 108-173). This legislation establishes a Medicare prescription drug benefit, effective January 1, 2006. In the interim, the legislation requires the Department of Health and Human Services (HHS) to establish a temporary program of Medicare-endorsed prescription drug discount cards. This report discusses the objectives and benefits of this legislation.
Date: March 24, 2005
Creator: Justice, Diane
Partner: UNT Libraries Government Documents Department
open access

Biologics and Biosimilars: Background and Key Issues

Description: This report discusses biologic and biosimilar medicines and their production and approval by the FDA. Recent legislation regarding FDA approval regulations and federal research and drug development are also discussed.
Date: October 27, 2017
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
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Biotechnology: Commercialization of Academic Research

Description: This report provides an overview of the commercialization of academic research h in the field of biotechnology. It offers a brief definition, background and policy analysis, as well as legislation and hearings regarding the topic.
Date: October 26, 1981
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
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Biotechnology, Indigenous Peoples, and Intellectual Property Rights

Description: This report examines intellectual property right in pharmaceuticals in a particular context, namely, medicinal products and processes derived from the biodiversity resources of areas inhabited by indigenous peoples. This report discusses the international law regarding intellectual property rights in traditional knowledge and the American laws regarding traditional knowledge.
Date: April 16, 1993
Creator: Axt, Josephie R.; Corn, M. Lynne; Lee, Margaret Mikyung & Ackerman, David M.
Partner: UNT Libraries Government Documents Department
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Bisphenol A (BPA) in Plastics and Possible Human Health Effects

Description: This report discusses Bisphenol A (BPA). BPA is used to produce certain types of plastic that are used in thousands of formulations for myriad products. Containers made with these plastics may expose people to small amounts of BPA in food and water. Medical devices and other more ubiquitous products, such as thermal paper coatings, also may contribute significantly to human exposure. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but … more
Date: August 13, 2010
Creator: Schierow, Linda-Jo & Lister, Sarah A.
Partner: UNT Libraries Government Documents Department
open access

Bisphenol A (BPA) in Plastics and Possible Human Health Effects

Description: Bisphenol A (BPA) is used to produce certain types of plastic. Containers made of these plastics may expose people to small amounts of BPA in food and water. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but scientists disagree about the value of the animal studies for predicting harmful effects in people. This report discusses this issue and relevant legislation, as well as inquiries into studies currently underway to determine the … more
Date: July 23, 2008
Creator: Schierow, Linda-Jo & Lister, Sarah A.
Partner: UNT Libraries Government Documents Department
open access

Bisphenol A (BPA) in Plastics and Possible Human Health Effects

Description: Bisphenol A (BPA) is used to produce certain types of plastic. Containers made of these plastics may expose people to small amounts of BPA in food and water. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but scientists disagree about the value of the animal studies for predicting harmful effects in people. This report discusses this issue and relevant legislation, as well as inquiries into studies currently underway to determine the … more
Date: June 30, 2008
Creator: Schierow, Linda-Jo & Lister, Sarah A.
Partner: UNT Libraries Government Documents Department
open access

Bisphenol A (BPA) in Plastics and Possible Human Health Effects

Description: Bisphenol A (BPA) is used to produce certain types of plastic. Containers made of these plastics may expose people to small amounts of BPA in food and water. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but scientists disagree about the value of the animal studies for predicting harmful effects in people. This report discusses this issue and relevant legislation, as well as inquiries into studies currently underway to determine the … more
Date: September 8, 2008
Creator: Schierow, Linda-Jo & Lister, Sarah A.
Partner: UNT Libraries Government Documents Department
open access

A Brief Summary of the HIPAA Medical Privacy Rule

Description: This report provides a brief overview of the modified HIPAA Privacy rule, “Standards for the Privacy of Individually Identifiable Health Information” (“privacy rule”) published on August 14, 2002 by the Department of Health and Human Services (HHS).
Date: April 30, 2003
Creator: Stevens, Gina Marie
Partner: UNT Libraries Government Documents Department
open access

A Brief Summary of the Medical Privacy Rule

Description: This report provides a brief overview of the modified medical privacy rule, “Standards for the Privacy of Individually Identifiable Health Information”(“privacy rule”) published on August 14, 2002 by the Department of Health and Human Services (HHS). The privacy regulation creates a new federal floor of privacy protections while leaving in place more protective state rules or practices. The rule establishes a set of basic consumer protections and a series of regulatory permissions for uses and … more
Date: February 14, 2003
Creator: Stevens, Gina Marie
Partner: UNT Libraries Government Documents Department
open access

A Brief Summary of the Medical Privacy Rule

Description: On March 27, 2002 the Department of Health and Human Services (HHS) published its proposed changes to the medical privacy regulations issued by the Clinton Administration under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). HHS is accepting comments on the proposed changes until April 26, 2002. This report provides an overview of the final rule for “Standards for the Privacy of Individually Identifiable Health Information” ( “privacy rule”) that went into effect on A… more
Date: April 10, 2002
Creator: Stevens, Gina Marie
Partner: UNT Libraries Government Documents Department
open access

A Brief Summary of the Medical Privacy Rule

Description: This report provides a brief overview of the recently modified medical privacy rule, “Standards for the Privacy of Individually Identifiable Health Information”(“privacy rule”) published on August 14, 2002 by the Department of Health and Human Services (HHS). The privacy rule went into effect April 14, 2001, with compliance required by April 2003 for most entities. The regulation creates a new federal floor of privacy protections while leaving in place more protective state rules or practices. … more
Date: August 27, 2002
Creator: Stevens, Gina Marie
Partner: UNT Libraries Government Documents Department
open access

Centers for Disease Control and Prevention Global Health Programs: FY2001-FY2010

Description: This report explains the role the Centers for Disease Control and Prevention (CDC) plays in U.S. global health assistance, highlights how much the agency has spent on global health efforts from FY2001 to FY2010, and discusses how funding to each of its programs changed during this period.
Date: August 21, 2009
Creator: Salaam-Blyther, Tiaji
Partner: UNT Libraries Government Documents Department
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Centers for Disease Control and Prevention Global Health Programs: FY2001-FY2011

Description: This report explains the role the Centers for Disease Control and Prevention (CDC) plays in U.S. global health assistance, highlights how much the agency has spent on global health efforts from FY2001 to FY2010, and discusses how funding to each of its programs has changed during this period.
Date: April 7, 2010
Creator: Salaam-Blyther, Tiaji
Partner: UNT Libraries Government Documents Department
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