Help us say Thank You at the 2012 AZBio Awards

On October 23rd Arizonans will be gathering from throughout the state at the Phoenix Convention Center for the 7th Annual AZBio Awards.  In addition to shining a spotlight on the achievements of our industry’s leaders, we will be using this opportunity to show our appreciation to the community that has supported the biosciences over the years.  The distance we have travelled isn’t merely measured in industry achievements.  Every Arizonan has contributed to our progress; either directly, as an innovator, researcher, leader, or investor, or indirectly as Arizona voters and taxpayers.Continue reading

FDA Comment Request: Establishing a unique device identification system for medical devices

The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. Continue reading

Performing Under PDUFA: The FDA Wants to Hear From You

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). Continue reading