Khin, N A

Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective. [electronic resource] - Clinical pharmacology and therapeutics Aug 2013 - 230-42 p. digital

Publication Type: Journal Article

1532-6535

10.1038/clpt.2013.70 doi


Antipsychotic Agents--therapeutic use
Cardiovascular Agents--therapeutic use
Clinical Trials as Topic--legislation & jurisprudence
Drug Approval--organization & administration
Guidelines as Topic
Humans
Internationality
Orphan Drug Production--statistics & numerical data
Pharmacology, Clinical--organization & administration
Research Design
United States
United States Food and Drug Administration--legislation & jurisprudence