14 results match your criteria Biotechnology Law Report[Journal]

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A Decade of Data Protection for Innovative Drugs in Canada: Issues, Limitations, and Time for a Reassessment.

Biotechnol Law Rep 2016 Dec;35(6):259-267

Drug regulators in Canada and in other nations require innovative pharmaceutical companies to submit undisclosed clinical or other data as a condition of approving the marketing of new pharmaceutical products-the origination of which involves considerable effort and investment. Data protection regulations were enacted in Canada in 2006, which-to some extent-closed a loophole in intellectual property law that had previously left innovative companies with no effective data protection for their clinical data. Although the regulations were intended to clarify and effectively implement Canada's international treaty obligations in the spirit of innovation, a review of Canada's first decade of effective data protection shows that Health Canada and Canadian courts have interpreted the scope of data protection for innovative drugs in a narrow manner that undermines and is inconsistent with the intent of the regulations. Read More

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http://dx.doi.org/10.1089/blr.2016.29030.mkDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5178005PMC
December 2016
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New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France*

Biotechnol Law Rep 2013 Dec;32(6):349-356

This article provides an overview of French legislative history, Parliamentary debates, and recent amendments in hESC research policy, as well as additional comparisons with laws across the European Union. Unlike policy discussions in the U.S. Read More

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http://dx.doi.org/10.1089/blr.2013.9865DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3869533PMC
December 2013

The Biofuels Tax Credit.

Authors:
Jane C Bergner

Biotechnol Law Rep 2013 Apr;32(1-2):1-2

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http://dx.doi.org/10.1089/blr.2013.9995DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3827853PMC
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