Sage Journals: Discover world-class research

Retricted access

Research article

First published 2019-1

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

Lewis J. Fermaglich, Ru Chen, Carol Y. Kim [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2019-9

Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics

Jason Woo, Jingyu (Julia) Luan, Zili Li [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2007-7

US FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System

Lawrence X. Yu, Andre Raw, Robert Lionberger [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted access

Review article

First published 2019-9

Generic drugs,a need to the public: USA and India – Government plans to reduce the price of abbreviated new drug application and list of generic drugs approved in year 2018

Russell Martin, Kavita Bahmani

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted access

Research article

First published 2004-02

FDA Issues Final Rule on Patent Listing Requirements and 30-Month Stays of Approval Following Submission of Abbreviated New Drug Applications

Barry J. Marenberg

Biotechnology Law Report

Retricted access

Research article

First published 2020

A Novel Development and Portfolio Management Strategy for Generic Small Molecule Drug Products: Watergile ANDA

Sandra Tomassini, Ajay Babu Pazhayattil, Marzena Ingram

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted access

Research article

First published 2013-9

Suitability petitions and Pediatric Research Equity Act evaluation—Basic understanding and recent case studies

Nirav Amitkumar Chokshi

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted access

Research article

First published 2019-3

An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application

Philip T. Lance, Ruth V. Greenaway, Brian Edwards

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2024-6

Generic entry and effect of market competition on outpatient pharmacy drug prices

Mohammed Jamjoom, Reem D Almutairi, Enrique Seoane-Vazquez [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted access

Research article

First published 2005-7

Teva v Pfizer: Creating an Uncertain Future for Generics Companies by De-Modernising the Medicare Modernization Act

Frederick H. Rein, Dominique T. Hussey

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Search results