FDA Drug Approval Statistics

It’s occurred to me to wonder just how many new drugs the US Food and Drug Administration (FDA) approves each year. The FDA is charged with the responsibility of ensuring the safety of foods, human and veterinary drugs, biological products, medical devices and cosmetics, for consumption and use by the American public. They also test electronic products for harmful radiation and, more recently, are investigating the safety of nanoparticles.

New product approvals can be viewed on the FDA website, listed by date and category (new drug applications, molecular entity drugs, accelerated/ priority or fast track applications). Statistics are given by fiscal year or calendar year, depending on the class you’re looking at.

When I looked under “What’s new by date” I found that this week alone, 4 products, listed under new and generic drug approvals, were approved, and several other products underwent labelling, formulation or other revisions. In the last fiscal year, 37 new drugs were submitted in the “fast track” approval program, designated for drugs to treat life-threatening illnesses that show exceptional potential to meet specific, as yet unaddressed, needs. 19 were approved, 6 denied, and the rest are pending. In the current calendar year (2007) 10 oncology (cancer) drugs have been approved.