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Follow-On Biologics: Intellectual Property and Innovation Issues

Description: Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.
Date: June 4, 2007
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
open access

Follow-On Biologics: Intellectual Property and Innovation Issues

Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Date: October 31, 2008
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
open access

Follow-On Biologics: Intellectual Property and Innovation Issues

Description: Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.
Date: March 5, 2007
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
open access

Follow-On Biologics: Intellectual Property and Innovation Issues

Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
open access

Follow-On Biologics: The Law and Intellectual Property Issues

Description: This report reviews the Biologics Price Competition and Innovation Act of 2009 (BPCIA), within the context of intellectual property and innovation issues. It provides an introduction to the biologics industry, introduces the regulatory and intellectual property provisions of the BPCIA, considers the potential market for biosimilars and possible industry responses that may arise in the wake of this legislation, and closes with concluding observations.
Date: January 15, 2014
Creator: Thomas, John R.
Item Type: Refine your search to only Report
open access

Food Additive Regulations: A Chronology

Description: The 104th Congress is actively debating proposals to reform several aspects of the Food and Drug Administration's (FDA) process for regulating consumer products, including its approval process for food additives. In June 1995, the Food and Drug Administration (FDA) announced at a House Government Reform and Oversight Subcommittee hearing several policy shifts in its food additive pre-market approval process which will soon be implemented.
Date: September 13, 1995
Creator: Vogt, Donna U.
Item Type: Refine your search to only Report
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Food and Agricultural Imports from China

Description: This report first provides information on the most recent Chinese-related food safety concern, the use of melamine in dairy ingredients. Following this section, the report provides data on U.S.-China trends in agricultural trade, examines U.S. programs to monitor the safety of imports, and reports on other recent Chinese food safety developments. It concludes with a brief discussion of the congressional role.
Date: September 26, 2008
Creator: Becker, Geoffrey S.
Item Type: Refine your search to only Report
open access

Food and Agricultural Imports from China

Description: This report details the information related to U.S. food and Agricultural imports from China. The contents include trade trends, U.S import safeguards, FDA import refusals, Chinese food safety challenges, and Congressional consideration
Date: January 2, 2008
Creator: Becker, Geoffrey S.
Item Type: Refine your search to only Report
open access

Food and Agriculture: Prospective Issues in the 105th Congress

Description: Implementation of major farm and food program changes enacted last year under omnibus farm (P.L.104-127) and welfare (P.L.104-193) measures is likely to draw the attention of the 105th Congress. The size and cost of these programs also could make them a target for reductions in congressional efforts to balance the budget.
Date: January 3, 1997
Creator: Jones, Jean Yavis
Item Type: Refine your search to only Report
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