ARTICLES BY GAIL DUTTON

• Pharma Field Trips: Is Hosting The FDA A Good Idea?

  3/8/2017

  Inviting FDA scientists into your manufacturing facility or laboratory for one or two days may feel unsettling, but it can be rewarding when the visits are designed to bring FDA scientists up to speed on real-world issues and new technologies.

• Cell Therapy Regulations Approach Their Inflection Point

  1/1/2017

  The need for discussions regarding guidelines for the development of therapeutics made from human cells, tissues, and cell- and tissue-based products has been building for a long time.