Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS

JAMA. 2018 Jan 2;319(1):21-22. doi: 10.1001/jama.2017.16477.

Authors

Jeanie Kim¹, Joseph S Ross^{1

2}, Amy Kapczynski¹

Affiliations

¹ Collaboration for Research Integrity and Transparency (CRIT), Yale Law School, New Haven, Connecticut.
² Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut.

PMID: 29117365
DOI: 10.1001/jama.2017.16477

No abstract available

MeSH terms

Child
Cinacalcet* / adverse effects
Cinacalcet* / therapeutic use
Clinical Trials as Topic* / legislation & jurisprudence
Clinical Trials as Topic* / standards
Drug Approval / legislation & jurisprudence*
Drug Industry / legislation & jurisprudence*
Drugs, Generic
Government Regulation
Humans
Hypercalcemia / drug therapy
Marketing / legislation & jurisprudence*
Patents as Topic / legislation & jurisprudence*
Pediatrics
United States
United States Food and Drug Administration*

Substances

Drugs, Generic
Cinacalcet