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