Header graphic for print
Focus on Regulation

Tag Archives: IND

FDA June 2, 2016 Final Guidances For Industry

On June 2, 2016, FDA issued three final Guidances for Industry—two of the three are aimed at clarifying the expanded access applications and procedures, while the third discusses charging for investigational drugs under an Investigational New Drug (IND) application.

NIH and FDA Announce Release of Draft Clinical Trial Protocol Template; Call for Comments by April 17, 2016

The National Institutes of Health (NIH) and Food and Drug Administration (FDA) announced on March 17, 2016, their co-development of a draft clinical trial protocol template for use by NIH-funded investigators.  The template is meant for use in writing phase 2 or 3 clinical trial protocols where Investigational New Drug application (IND) or Investigational Device

D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies

The D.C. Circuit has issued a ruling that will shape the future development of stem cell therapy in the United States.  Through its February 4 decision, the court has broadly upheld FDA’s authority to regulate stem cell therapies as drugs.  Thus, any sense that the development of such therapies may be exempt from the pre-market approval