FDA has about 200 pediatric supplements pending after eight approvals so far in 1997.
FDA PEDIATRIC LABELING SUPPLEMENTAL APPROVALS TOTAL EIGHT IN 1997 from submissions to the agency from manufacturers in response to pediatric labeling regulations proposed in 1994. The agency estimated that approximately 200 pediatric supplements have been submitted in response to the regs, although it does not have an estimate of how many of those submissions contain data to support a new pediatric claim. Supplements were due at FDA under the 1994 rule in April. The Clinton Administration has interpreted the 1994 rule as an unsuccessful attempt to encourage appropriate pediatric labeling and issued a proposed rule to mandate pediatric studies on Aug. 13 ("The Pink Sheet" Aug. 18, p. 3-7).
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