Drugs

Books & Primers

How to Comply with cGMPs

April 2013

Instant Access, Purchase and Download Now by Cathy Burgess; Appendix by Neil Di Spirito All pharmaceutical and biologics stakehold...

Top 20 Food and Drug Cases, 2012 & Cases to Watch 2013

April 2013

Published for the fourth consecutive year, the Top 20 Cases book, featuring analysis and discussion of the most important food and drug c...

Effective Review and Approval of Digital Promotional Tactics

March 2013

Instant Access, Purchase and Download Now by Dale Cooke Food and Drug Administration enforcement action for promotional activities remai...

Food & Drug Law Journal

Your Business in Court and at Federal Agencies: 2011-2012, 68 Food and Drug Law Journal, 1‑52 (2013).

March 2013

FDA transparency effort continued, including the Secretary’s adopting eight measures to improve access to Agency information and ac...

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...