FDA Update: Week Of January 10, 2011

By Lori Clapper, Web Editor

Breakthrough For Vision Loss
The FDA approved an Investigational New Drug (IND) application for a new embryonic stem cell therapy to treat patients with dry age-related macular degeneration (AMD), the most common form of macular degeneration in the world. Advanced Stem Cell Technology, Inc. announced it is now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with dry AMD. There are currently no treatments available for this disease, and the incidence of AMD is projected to double in the next 20 years.

Read the entire announcement from Advanced Stem Cell Therapy.

New Website To Help Regulated Industries
Last Thursday, the FDA introduced a new web resource called FDA Basics for Industry to help improve companies' interactions with the agency. This resource is one of the 19 action items in the agency's ongoing Transparency Initiative, launched by Commissioner Hamburg in 2009. The site features questions, answers, videos, and other materials describing how the FDA works.

Read the Transparency Initiative report.

Find out more in the FDA's announcement.

FDA Clinical Trial Requirements Regulations, Compliance, And GCP Conference
This two-day conference is intended to share information among FDA representatives and the regulated community; to facilitate the understanding of regulations, guidelines, and practices; and to suggest methods and opportunities to enhance the research professional's product development experience. Find out where you can attend.