How to Comply with cGMPs

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

Instant Access, Purchase and Download Now by Cathy Burgess; Appendix by Neil Di Spirito All pharmaceutical and biologics stakeholders should understand the importance of compliance with and ...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

The Medical Device Review Process: A Focus on Pre-Market Requirements

Posted on October 2012 by Michele L. Buenafe, Esq.

Instant Access, Purchase and Download Now by Michele L. Buenafe, Esq. The Medical Device Review Process: A Focus on Pre-Market Requirements Primer will explain, in practical terms, the ...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

Biosimilar Law and Regulation: An Essential Guide

Posted on May 2011 by Erika Lietzan

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 Biologics Price Comp...read more

A Practical Guide to Navigating the Medical Device Industry: Advice from Experts in Industry, Law, Intellectual Property and Academia

Posted on May 2011 by Joanna Brougher, Michael M. Gaba, Mark Deem, Roseann B. Termini, Kalah Auchinocioss

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 United States is a g...read more

Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products

Posted on March 2011 by Melanie M. Fairchild-Dzanis, Sarah Roller

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 Admini...read more