Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective. [electronic resource]
Producer: 20130930Description: 230-42 p. digitalISSN:- 1532-6535
- 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
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Publication Type: Journal Article
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