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Research article

First published 2016-9

Product Development Under FDA’s Animal Rule

Theresa Allio

Therapeutic Innovation & Regulatory Science

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Other

First published 2000-7

The Food and Drug Administration Modernization ACT and the Food and Drug Administration: Metamorphosis or Makeover?

Christopher-Paul Milne

Therapeutic Innovation & Regulatory Science

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Other

First published 2000-7

An Overview of an Initial Experience with a Medication Guide

Cynthia P. Chianese

Therapeutic Innovation & Regulatory Science

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Other

First published 2009-1

Stringent Laws and Regulations for Dietary Supplements

Tao Jiang, Shu Zhang

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-5

Repositioning Generics: The Comparative Value of Liability in FDA's Proposed Rule on Labeling

Nicholas Falcone

American Journal of Law & Medicine

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Other

First published 1996-9

The FDA's Proposed Rules Regulating Tobacco and Underage Smoking and the Commercial Speech Doctrine

Ross D. Petty, Sandra E. McKay, Mary Jane Dundas [...]

Journal of Public Policy & Marketing

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Other

First published 2003-10

Revised FDA Rules regarding Orange Book Listings under the Hatch-Waxman Act

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

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Research article

First published 2007-02

Senate Finally Approves Von Eschenbach as FDA Commissioner;FDA Proposes New Rules for Access to Experimental Drugs;Submitting Genomics Data to FDA;GAO Looks at Drug Development;Too Much Epo?

Biotechnology Law Report

Open access

Research article

First published 2014-7

Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

Judith M. Kramer, David Vock, Howard E. Greenberg [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-12

What companies need to know about FDA’s Final Rule on ANDAs and 505(b)(2) applications

Paul A Braier

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

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