Hatch Waxman Act - Pharma

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Relevant Publications

Generic Drugs and the Struggle to Compete: The Role of Skinny Labels.

Issue Release: 2024

Patent Challenges And Litigation On Inhalers For Asthma And COPD.

Issue Release: 2023

The story of the development of generic lenalidomide: How one company thwarted the Waxman-Hatch Act to generate billions of dollars in revenue.

Issue Release: 2023

Fixing The FDA\'s Orange Book.

Issue Release: 2022

FDA Approval and Regulation of Pharmaceuticals, 1983-2018.

Issue Release: 2020

Regulating Generic Ophthalmologic Drug Bioequivalence-Envisioning Accessibility for Patients.

Issue Release: 2020

Generic Drug Policy and Suboxone to Treat Opioid Use Disorder.

Issue Release: 2019

Should a Law Governing the Pharmaceutical Market Be Ethically Examined Based on Its Intent or Its Practical Applications?

Issue Release: 2019

Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States.

Issue Release: 2018

Generic Drug Approvals Since the 1984 Hatch-Waxman Act.

Issue Release: 2016

Updated trends in US brand-name and generic drug competition.

Issue Release: 2016

How drug life-cycle management patent strategies may impact formulary management.

Issue Release: 2016

An Administrative Meter Maid: Using Inter Partes Review and Post-Grant Review to Curb Exclusivity Parking via the \"Failure to Market\" Provision of the Hatch-Waxman Act.

Issue Release: 2015

Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers.

Issue Release: 2015

Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era?

Issue Release: 2015

Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.

Issue Release: 2015

Research use exemptions to patent infringement for drug discovery and development in the United States.

Issue Release: 2014

Revitalizing the patent system to incentivize pharmaceutical innovation: the potential of claims with means-plus-function clauses.

Issue Release: 2013

The economics of biosimilars.

Issue Release: 2013

Recent trends in brand-name and generic drug competition.

Issue Release: 2013

What is Medication Adherence?

What Are Clinical Trials?

What are the Challenges in Implementing Collaborative Care Models?

What is the Future of ADE Management?

Why Are Clinical Trials Important?

What are Collaborative Care Models?

How are ADEs Different from Side Effects?

Why are Collaborative Care Models Important in Pharma?

Why do Pharma Companies Use CROs?

How are New Drugs Discovered?

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