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 The FDA says it incorporated feedback from a related proposal from 2010 that was later withdrawn.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
Sr. Regulatory Specialist, Biotech Center of Expertise
BASF, The Chemical Co.
San Diego, CA
Food Lawyer
Cargill
Wayzata, MN
Director of Clinical Research
Regenesis Biomedical, Inc.
Scottsdale, AZ
Actuary
Meridian Health Plan
Detroit, MI
Assistant Vice President - Dental Director
MetLife
Bridgewater, NJ