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

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

Instant Access, Purchase and Download Now by Carolyne Hathaway, John Manthei, Elizabeth Richards and Eitan Bernstein In 2010, the Biologics Price Competition and Innovation Act of 2009 created ...read more

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

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

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 Admini...read more