Animal Drugs

Books & Primers

Food and Drug Law and Regulation, 3rd Edition

December 2014

Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in ...

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...

Articles

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 ...

Winckler to Step Down as FDLI President and CEO; Recruitment Underway

March 2014

The Food and Drug Law Institute, the premier educational organization in the field of food and drug law, announced today that President a...

The Food and Drug Law Institute To Honor Axelrad, Gibbs, Holcombe, Kingham

December 2013

Honorees Will Receive Distinguished Service and Leadership Awards at Holiday Reception December 10 December 5, Washington, DC -- The Food...

Constitutionality of State Biosimilar Substitution Bills Is Focus of New FDLI Food and Drug Law Policy Forum

September 2013

“Do Pending State Biosimilar Substitution Bills Violate State Constitutional Law Principles of Non-Delegation and Incorporation by ...

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: 2010-2011, 67 Food and Drug Law Journal, 243-292 (2012).

June 2012

This year the government aggressively pursued Manufacturers under the enhanced provisions of the False Claims Act (FCA), as well as un...

Closing the Information Gap: Informing Better Medical Decisionmaking through the Use of Post-Market Safety and Comparative Effectiveness Information, 67 Food and Drug Law Journal, 83-102 (2012)

March 2012

Second Prize, Short Paper, H. Thomas Austern Memorial Writing Competition, 2011. While FDA gathers vast amounts of data about prescripti...