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Items: 14

1.
FDA's Expedited Approval Mechanisms for New Drug Products
Erin E. Kepplinger
Biotechnol Law Rep. 2015 Feb 1; 34(1): 15–37. doi: 10.1089/blr.2015.9999
PMCID:
PMC4326266
ArticlePubReaderPDF–246KCite
2.
The History of Technology Assessment and Comparative Effectiveness Research for Drugs and Medical Devices and the Role of the Federal Government
Jennifer Wong
Biotechnol Law Rep. 2014 Dec 1; 33(6): 221–248. doi: 10.1089/blr.2014.9967
PMCID:
PMC4270161
ArticlePubReaderPDF–576KCite
3.
New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France*
By Katherine Drabiak-Syed
Biotechnol Law Rep. 2013 Dec 1; 32(6): 349–356. doi: 10.1089/blr.2013.9865
PMCID:
PMC3869533
ArticlePubReaderPDF–165KCite
4.
Biosimilarity and Interchangeability in the Biologics Price Competition and Innovation Act of 2009 and FDA's 2012 Draft Guidance for Industry
Hannah Koyfman
Biotechnol Law Rep. 2013 Aug; 32(4): 238–251. doi: 10.1089/blr.2013.9884
PMCID:
PMC3827854
ArticlePubReaderPDF–295KCite
5.
Does Inherency Have a Place in Determinations of Obviousness?
Daniel P. O'Brien, W. Murray Spruill
Biotechnol Law Rep. 2013 Apr; 32(1-2): 3–16. doi: 10.1089/blr.2013.9994
PMCID:
PMC3827852
ArticlePubReaderPDF–284KCite
6.
A Decade of Data Protection for Innovative Drugs in Canada: Issues, Limitations, and Time for a Reassessment
Megan Kendall, Declan Hamill
Biotechnol Law Rep. 2016 Dec 1; 35(6): 259–267. Published online 2016 Dec 1. doi: 10.1089/blr.2016.29030.mk
PMCID:
PMC5178005
ArticlePubReaderPDF–108KCite
7.
Innovative Medicines Initiative (IMI) Case Study Analysis Reveals the True Added Value of Early-Phase Public-Private Partnerships (PPPs)
DR. Hilde Stevens, DR. Geertrui Van Overwalle, DR. Bart Van Looy, DR. Isabelle Huys
Biotechnol Law Rep. 2015 Aug 1; 34(4): 153–165. doi: 10.1089/blr.2015.29008.hs
PMCID:
PMC4574745
ArticlePubReaderPDF–245KCite
8.
Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response to Our Divided Patent System
Christopher M. Holman
Biotechnol Law Rep. 2015 Apr 1; 34(2): 59–67. doi: 10.1089/blr.2015.9993
PMCID:
PMC4410186
ArticlePubReaderPDF–184KCite
9.
Claim Construction Cannot Save a Modified Gene Invention Claimed with a Scientifically Debatable Biological Mechanism: A Lesson from Bayer CropScience AG v. Dow AgroSciences LLC, 728 F.3d 1324 (Fed. Cir. 2013)
Ping-Hsun Chen
Biotechnol Law Rep. 2014 Dec 1; 33(6): 209–219. doi: 10.1089/blr.2014.9970
PMCID:
PMC4270148
ArticlePubReaderPDF–116KCite
10.
Recent Decisions of the European Court of Justice of the European Union on Supplementary Protection Certificates: A Few Answers—Many Questions
Dr. Franz-Josef Zimmer, Dr. Benjamin Quest, Dr. Markus Grammel
Biotechnol Law Rep. 2014 Oct 1; 33(5): 171–180. doi: 10.1089/blr.2014.9974
PMCID:
PMC4208616
ArticlePubReaderPDF–170KCite
11.
Who Owns the Intellectual Property Rights to Chinese Genetically Modified Rice? Evidence from Patent Portfolio Analysis
Lijun Liu, Cong Cao
Biotechnol Law Rep. 2014 Oct 1; 33(5): 181–192. doi: 10.1089/blr.2014.9971
PMCID:
PMC4208608
ArticlePubReaderPDF–404KCite
12.
Informed Consent and Ethical Review in Chinese Human Experimentation: Reflections on the “Golden Rice Event”
Xiang Yu, Wei Li
Biotechnol Law Rep. 2014 Aug 1; 33(4): 155–160. doi: 10.1089/blr.2014.9979
PMCID:
PMC4132579
ArticlePubReaderPDF–130KCite
13.
Epigenetic Patents: A Stressful Environment for an Emerging Science
William Noonan, Adria Decker Dismuke, Mitchell S. Turker
Biotechnol Law Rep. 2013 Oct; 32(5): 302–312. doi: 10.1089/blr.2013.9868
PMCID:
PMC3827855
ArticlePubReaderPDF–246KCite
14.
The Biofuels Tax Credit
Jane C. Bergner
Biotechnol Law Rep. 2013 Apr; 32(1-2): 1–2. doi: 10.1089/blr.2013.9995
PMCID:
PMC3827853
ArticlePubReaderPDF–44KCite

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