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Books & Primers

A Practical Guide to FDA’s Food and Drug Law and Regulation -5th Edition

April 2014

A Practical Guide to Food and Drug Law and Regulation provides a basic introduction to the laws and regulations that govern the developme...

FDCA Statutory Supplement, 2013

December 2013

FDCA Statutory Supplement, 2013 Edited by Joy Liu, Esq Why spend countless hours trying to piece together recent amendments to the Feder...

A Practical Guide to FDA's Food and Drug Law and Regulation, 4th Edition

April 2012

The Fourth Edition of A Practical Guide to FDA's Food and Drug Law and Regulation updates and expands the widely-used Third Edition, incl...

Articles

E-cigarettes: A life-saving technology or a way for tobacco companies to re-normalize smoking in American Society?

July 2014

This issue of Policy Forum, written by Joel Nitzkin, focuses on e-cigarettes and recommend adding a tobacco harm reduction component to t...

E-cigarettes: A Life-Saving Technology or a Way for Tobacco Companies to Re-Normalize Smoking in American Society?

July 2014

E-cigarettes are an increasingly hot topic in the tobacco world, especially after the release of FDA’s proposed deeming regulations...

FDLI Names New President and Chief Executive Officer

May 2014

FDLI Names New President and Chief Executive Officer Amy Comstock Rick to lead organization effective August 25th The Food and Drug Law ...

Food & Drug Law Journal

Does Sackett Foreshadow the End of Non-Reviewability for FDA Warning Letters?, 68 Food and Drug Law Journal, 241-258 (2013).

August 2013

FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedur...

Your Business in Court and at Federal Agencies: 2011-2012, 68 Food and Drug Law Journal, 1‑52 (2013).

March 2013

FDA transparency effort continued, including the Secretary’s adopting eight measures to improve access to Agency information and ac...

Toward a Comprehensive Policy on Nicotine Delivery Products and Harm Reduction, 67 Food and Drug Law Journal, 393 404 (2012).

December 2012

Implementation of the Family Smoking Prevention and Tobacco Control Act is resulting in FDA establishing a comprehensive tobacco policy, ...