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 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 more

The Regulation of Follow-on Biologics: FDA Authority and Implementation

Posted on December 2013 by Carolyne Hathaway, John Manthei, Elizabeth Richards and Eitan Bernstein

By Carolyne Hathaway, John Mantei, Elizabeth Richards, Eitan Bernstein, Latham & Watkins LLP Biologics are among the healthcare industry’s most complex and expensive drugs. In 2010, the 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) 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 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 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 more

Effective Advocacy in FDA Matters

Posted on October 2010 by James Czaban, Bert Rein

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. The Food and Drug more