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Page 3 REQUIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act PREA 21 U.S.C. 355c all applications for new active ingredients new indications new dosage forms new dosing regimens or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication s in pediatric patients unless this requirement is waived deferred or inapplicable. We are waiving the pediatric study requirement for ages 0 to less than 4...
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203093orig1s000 - fda is a form submitted to the FDA for regulatory purposes.
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Manufacturers, distributors, and importers of certain FDA-regulated products are required to file 203093orig1s000 - fda.
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The purpose of 203093orig1s000 - fda is to provide the FDA with important information about regulated products, including safety and efficacy data.
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