Regulatory Roundup: FDA Awards Grants for Pediatric Medical Devices, More...

September 24, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, FDA extended the deadline for the pilot program for the submission of CMC information.

The US Food and Drug Administration is awarding $2 million in grants for the development of pediatric medical devices, according to a Sept. 21, 2009, agency release. Sixteen companies applied for the grants, which will be administered by FDA’s Office of Orphan Products Development (OOPD). The grantees are: Dr. James Geiger and the Michigan Pediatric Device Consortium ($1 million), Dr. Pedro DelNido and the Pediatric Cardiovascular Device Consortium ($500,000), and Dr. Michael Harrison and the University of California at San Francisco Pediatric Device Consortium ($500,000). OOPD Director Timothy Cote said in the release that Congress provided the funds based on medical device legislation passed in 2007 to “help connect innovators and their ideas with experienced professionals who assist them through development.” The grants are meant to help “effectively meet the special and unique needs of our children.”

FDA is extending the deadline to Sept. 30, 2010 for those wishing to participate in the Office of Biotechnology Product’s pilot program for the submission of chemistry, manufacturing, and controls (CMC) information. The pilot is modeled after the Office for New Drug Quality Assessment’s CMC Pilot Program focused on quality-by-design principles.