FDA Considering Alternative Approval Pathway

from FDA Law Blog
By Alexander J. Varond 

FDA announced earlier this week that it will hold a public hearing to obtain input on a potential new pathway to expedite the development of drugs and biological products for serious or life-threatening conditions that would address an unmet medical need. The new pathway would be used to approve drugs studied in well-defined subpopulations of patients with more serious manifestations of a condition. By focusing on patients with more serious manifestations of a condition, the pathway opens the door to the use of smaller and faster clinical trials. This approach was recently outlined in FDA’s draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” We wrote about that draft guidance here. FDA notes that by focusing on obtaining approval in well-defined, sicker subpopulations, the risk-benefit considerations may favor approval compared with trials that aim for approval in broader groups of patients with wide ranges of clinical manifestations. The potential new approval pathway could also help reduce the development of resistance to antibacterial drugs by limiting their use to certain patients.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/01/fda-considering-alternative-approval-pathway.html