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
Author Archive: AZBio
Supreme Court Obamacare Ruling Fast Tracks Healthcare Issues
A Guest Post By Larry Aldrich, Executive Director, Arizona Business Coalition on HealthContinue reading
Biochemist awarded ASU’s coveted Galvin Professorship
An expert in the structural biochemistry and biophysics of membrane proteins, ASU’s Galvin Professor Petra Fromme’s research efforts and multi-institution team are revolutionizing core understanding about infectious disease and creating exciting developments in medicine and clean energy. Continue reading
Comments Needed: SBA Releases Proposed SBIR & STTR Regulations
SBIR Inside Track: SBA Releases Proposed SBIR & STTR Regulations. Open for Public Comment Until July 16, 2012Continue reading
Flagship Sails Into New Waters With Expansion Into Neuroscience Pathology Services
Flagship Biosciencs expands quantitative histopathology services into neurodegenerative disease and neurotoxicity
Stereological and classical image analysis approaches help to more accurately quantify neuropathology and model treatment efficacyContinue 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
Sensitive test helps improve vaccine safety
ASU Professor earns $6.25M research award from Department of Defense
ASU professor Hao Yan, an innovator in the field of nanotechnology, has been selected to receive a five-year, $6.25 million basic research award under the Department of Defense’s (DoD) Multidisciplinary University Research Initiative (MURI) program.Continue reading
New Technology Helps Patients Suffering Joint Damage
“It’s a stroke of genius to combine tissue engineering and improved implant measurement technology,” said Jennifer Barton, head of the UA biomedical engineering department. “No one really knew what the specific loads were on these joints before this.”Continue reading
Independence and Innovation
A 4th of July Message from AZBioContinue reading