But FDA says response from the pharmaceutical industry is underwhelming, even after the agency extended the deadline for supplemental applications to April 6, 1997. In November, FDA sent a letter to 250 manufacturers asking whether and when companies intended to file supplements. FDA received only 40 responses by December. FDA said the absence of adequate pediatric labeling "continues to present a significant health issue" and added that the level of response to the 1994 final rule is a cause for concern.
FDA worried about pediatric drug labeling
The Food & Drug Administration (FDA) continues its effort to ensure that drug labels contain sufficient information about use for children. In December '94, FDA required manufacturers to determine if the pediatric use sections of labeling could be modified "based on adequate and well-controlled studies in adults and other supporting information." Companies would then submit a supplemental pediatric application where appropriate.
Jan 31, 1997
Recommended
Machinery Basics
Get a jump on your 2026 packaging & processing goals at PACK EXPO East.
Be the first to find what’s next in packaging & processing at PACK EXPO East. See new solutions from 500 exhibitors, uncover creative ideas for 40+ verticals and gain inspiration from free sessions on industry trends—all in one trip to Philadelphia.
REGISTER NOW & SAVE
Annual Outlook Report: Workforce
Hiring remains a major challenge in packaging, with 78% struggling to fill unskilled roles and 84% lacking experienced workers. As automation grows, companies must rethink hiring and training. Download the full report for key insights.
Download Now
Downloads
