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
Recommended
Machinery Basics
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Coding, Marking, and Labeling Innovations Report
Explore our editor-curated report featuring cutting-edge coding, labeling, and RFID innovations from PACK EXPO 2024. Discover high-speed digital printing, sustainable label materials, automated labeling systems, and advanced traceability solutions that are transforming packaging operations across industries.
Access Report
