Assessing Drug Safety in Children - The Role of Real-World Data

N Engl J Med. 2018 Jun 7;378(23):2155-2157. doi: 10.1056/NEJMp1802197.

Authors

Ann W McMahon¹, Gerald Dal Pan¹

Affiliation

¹ From the Office of Pediatric Therapeutics (A.W.M.), and the Office of Surveillance and Epidemiology (G.D.P.), Food and Drug Administration, Silver Spring, MD.

No abstract available

MeSH terms

Advisory Committees
Child
Consumer Product Safety / legislation & jurisprudence*
Drug-Related Side Effects and Adverse Reactions*
Humans
Legislation, Drug
Medical Device Legislation
Product Surveillance, Postmarketing*
Safety
United States
United States Food and Drug Administration / legislation & jurisprudence

Grants and funding

FD999999/Intramural FDA HHS/United States