What is the vision at the Food and Drug Administration?
I take a look at the contradictory world of the FDA – especially as it relates to the ophthalmology industry -in a piece for MillennialEye.
Progress:”Through the political maelstrom and bureaucratic twists and turns, there is progress, according to Carl Tubbs, MD, an ophthalmologist with InSight Vision Group in Denver, a member of the American Glaucoma Society and president of the American National Standards Institute.
“We have seen a willingness from the FDA to move standard development forward in a more direct path,” he says. “The process has included the presence of more consistently involved FDA members in the standards process so that our team is more familiar with ongoing issues and we do not need to readdress them, and what I perceive is better inter-departmental communication within the FDA itself.”
The FDA is moving along with the approval process, but it is still understaffed and occasionally stumbles in bureautic obstacles.
“The (FDA) is a vision of two worlds: the focus of major regulatory reform that aims to hasten the approval process for high-quality drugs and devices, but also a federal agency significantly understaffed and bogged down in bureaucratic uncertainty,” the article states
It adds: “The FDA has taken steps in recent years to improve its review and evaluation of drugs and devices, recently becoming more efficient, for instance, than the European Medicines Agency (EMA), its counterpart agency in Europe. FDA officials also say they are now working closer than ever with private industry to develop product innovations and move products quicker to market”. — Joe Cantlupe