Biologics

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 ...

The Basics of Biostatistics in FDA Regulation – An FDLI Primer

November 2014

Instant Access, Purchase and Download Now By Coleen Klasmeier, Partner, Sidley Austin LLP; Ryan Kaat, Associate, Sidley Austin LLP Biosta...

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...

Articles

Biosimilar Nomenclature: Can we Achieve the Truth, the Whole Truth, & Nothing but the Truth?

September 2014

Issue 8 of the FDLI Policy Forum, written by Peter Pitts, focuses on biosimilar nomenclature and recommends that FDA require differential...

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...

FDA’s Social Media Draft Guidance Is Focus of New FDLI Food and Drug Law Policy Forum

February 2014

“Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?&rdqu...

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...

FDA’s Evolving Approach to Nanotechnology, 67 Food and Drug Law Journal, 405-411 (2012).

December 2012

Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulat...

Direct-to-Consumer Genetic Testing: Learning from the Past and Looking toward the Future, 67 Food and Drug Law Journal, 413-433 (2012).

December 2012

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to...