FDAsafety guidance95% confidence
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to FDA Issues Guidance on Postapproval Pregnancy Safety Studies; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to Written Request issued under the BPCA and pediatric assessments conducted under PREA.
Supporting Context
- Therapeutic area
- General · Drug Safety
- Sub-indication
- General
Related signal: FDA Issues Guidance on Postapproval Pregnancy Safety Studies