FDA proposal would require pediatric data in submissions

02/21/2013 | Bloomberg BNA (free content)

The FDA has issued a supplemental proposal mandating that medtech firms include data on pediatric patients when applying for premarket approval or a PMA supplement, a humanitarian device exemption request and a product development protocol. The FDA says it incorporated feedback from a related proposal from 2010 that was later withdrawn. The proposal is up for comment through April 22.

View Full Article in:

Bloomberg BNA (free content)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Senior Director, Research
America's Health Insurance Plans (AHIP)
Washington, DC
Stop Loss Sales Executive
Blue Cross Blue Shield of MA
Boston, MA
Regional Director, Southeastern Region - State Affairs
America's Health Insurance Plans (AHIP)
Washington, DC
Field Representative-Oklahoma and Kansas
National Rural Electric Cooperative Association (NRECA)
Multiple Locations, SL_Multiple Locations
Market Intelligence Manager
Olympus Corporation of the Americas
Southborough, MA