By Marc C. Sanchez, Contract In-House Counsel and Consultants, LLC This resource offers an overview of the regulation of food from the postmarket enforcement perspective. Readers will obtain a ful...read more

The Basics of Biostatistics in FDA Regulation – An FDLI Primer

Posted on November 2014 by Coleen Klasmeier, Partner, Sidley Austin LLP; Ryan Kaat, Associate, Sidley Austin LLP

By Coleen Klasmeier and Ryan Kyaat, Sidley Austin LLP Decision making by the Food and Drug Administration (FDA) regularly involves the use of biostatistics, and yet, there is relatively little dis...read more

Pharmacy Compounding: The New Legislation and Essential Background — An FDLI Primer

Posted on July 2014 by Rachael G. Pontikes, Partner, Duane Morris LLP; Foreword by Elizabeth R. Jungman, Senior Health Policy Advisor, U.S. Senate HELP Committee

Edited by Rachel G. Pontikes, Patrick C. Gallagher, and Elinor L. Hart, Duane Morris LLP A comprehensive overview of the legislative history of federal pharmacy compounding oversight, The Regulati...read more

How to Comply with cGMPs

Posted on April 2013 by Cathy Burgess; Appendix by Neil Di Spirito

By Cathy L. Burgess, Guillermo Cuevas, and Laura Sierra, Alston & Bird LLP The U.S. Food and Drug Administration’s (FDA’s) standards for current Good Manufacturing Practice (cGMP) c...read more

Instant Access, Purchase and Download Now by Dale Cooke Food and Drug Administration enforcement action for promotional activities remains vigorous, and digital tactics receive more than their fai...read more

The Drug/Biologics Approval Process: An FDLI Primer

Posted on January 2013 by Brian Malkin and Scot Pittman

Instant Access, Purchase and Download Now by Brian Malkin and Scot Pittman This publication will explain, in practical terms, the approval processes for drugs and biologics. It will ...read more

The Cosmetics Regulatory Process

Posted on January 2013 by Elizabeth H. Anderson and Farah K. Ahmed

Instant Access, Purchase and Download Now by Elizabeth H. Anderson and Farah K. Ahmed The Cosmetics Regulatory Process primer provides a thorough baseline of key legal concepts and issues from...read more

Controlled Substances: FDA and DEA Regulation of Pharmaceuticals

Posted on June 2012 by Lynn W. Mehler, Esq. and David M. Fox, Esq.

Instant Access, Purchase and Download Now by Lynn W. Mehler, Esq. and David M. Fox, Esq. “Controlled Substances: FDA and DEA Regulation of Pharmaceuticals” is a must-have Primer ...read more

The New Reality of Sales Force Behavior and Management

Posted on June 2011 by John Oroho, Kenneth R. Meyer, Lauren E. Handler

About This Monograph Prior to 2012, FDLI published the FDLI Monograph Series, which consisted of six monographs annually. We now publish 4 to 6 Primers each year. Life sciences companies ...read more

Utilizing REMS to Mitigate the Safety Risks of Pharmaceuticals

Posted on November 2010 by Gary H. Slatko, Linda J. Scarazzini, Kathleen M. Sanzo

About This Monograph Prior to 2012, FDLI published the FDLI Monograph Series, which consisted of six monographs annually. We now publish 4 to 6 Primers each year. In 2009, the Food and D...read more