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- Newly Added Guidance DocumentsGuidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – presentThe following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
- Pediatric Exclusivity StatisticsPediatric Exclusivity Statistics updated list.
- Drugs@FDA Download File (new structure)Drugs@FDA Data files updated weekly
- Drugs@FDA Data FilesDrugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)