Primers

These 80-120 page, practical, user-friendly Primers are instantly available to you in PDF form online. These reports are extensively researched, referenced and edited by some of the most experienced and respected professionals in the field. And, just like our flagship publication, the Food and Drug Law Journal (which has been published for more than six decades) you can rely on FDLI's reputation for fair, unbiased analysis and extensive and valuable sourcing and citation.

The Primers are designed to provide you with information and proprietary analysis to enable you to advise your clients or help your company comply with vexing issues, regulations and guidance. Each Primer is focused on a current issue that you or someone else at your firm or company is working on today — or tomorrow. And all Primers provide specific how-to guidance that will give you a thorough understanding of a complicated and often perplexing issue.

Be on the lookout for these upcoming Primers:

  • Guide to U.S. Import Requirements for Food



Primers

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

December 2013

Instant Access, Purchase and Download Now by Carolyne Hathaway, John Manthei, Elizabeth Richards and Eitan Bernstein In 2010, the Bio...

FDA’s Regulation of Veterinary Drug Products

September 2013

Instant Access, Purchase and Download Now by Hughes-Coons and Nobert FDA Regulation of Animal Drug Products is a primer for stakeholder...

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...