Search Result "Hatch Waxman"


The Hatch-Waxman Act: Encouraging Innovation and Generic Drug Competition

Journal: Current Topics in Medicinal Chemistry
Volume: 10 Issue: 1 Year: 2010 Page: 1950-1959
Author(s): Allen M. Sokal, Bart A. Gerstenblith

Drug Discovery and the Impact of the Safe Harbor Provision of the Hatch-Waxman Act

Journal: Current Topics in Medicinal Chemistry
Volume: 10 Issue: 1 Year: 2010 Page: 1960-1970
Author(s): Susanne H. Goodson

Review Article

The Breakthrough Hatch Waxman Amendment – A Shared Benefit for Innovations and Subsequent Innovations

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 4 Issue: 2 Year: 2017 Page: 86-90
Author(s): Sandeep Kumar Dhiman,Anju Dhiman,Shelly Khurana,Vikram Gummadi,Anjali Saharan

Editorial [Hot topic: Recent Intellectual Property Law Changes and their Impact on Drug Discovery (Guest Editor: William A. Kinney)]

Journal: Current Topics in Medicinal Chemistry
Volume: 10 Issue: 1 Year: 2010 Page: 1927-1928
Author(s): William A. Kinney

Editorial free to download

Editorial:Regulatory Audit and Compliance in Life Science Domain

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 4 Issue: 2 Year: 2017 Page: 85-85
Author(s): Swagat Tripathy,Harish Dureja

Big Pharma's Recent Challenges

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 1 Issue: 1 Year: 2014 Page: 28-36
Author(s): Harish Dureja,Neelam Dalal,Swagat Tripathy

The Case of Biotech-Derived Product Equivalence: Much Ado About Nothing?

Journal: Current Clinical Pharmacology
Volume: 1 Issue: 2 Year: 2006 Page: 147-156
Author(s): Jorge Duconge

Review Article

A Comprehensive Overview on Biosimilars

Journal: Current Protein & Peptide Science
Volume: 17 Issue: 8 Year: 2016 Page: 756-761
Author(s): Vishruti Kadam,Shapali Bagde,Manisha Karpe,Vilasrao Kadam

Regulatory Review of Abbreviated Biologics Regulations in ICH Countries

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Volume: 1 Issue: 3 Year: 2014 Page: 169-175
Author(s): Venkatesh Madhugiri Prakash,Chethan Kumar Reddy,Pramod Kumar Teggin Math

The Forward Path for Biopharmaceuticals and Biosimilars: Emerging Options in the Selection of Host Cell Systems

Journal: Current Biotechnology
Volume: 1 Issue: 4 Year: 2012 Page: 297-317
Author(s): Krista Wager,Graham Jones

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