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New Drug Approval : FDA's Consideration of Evidence from Certain Clinical Trials.
- Format:
- Book
- Government document
- Author/Creator:
- United States. Government Accountability Office.
- Language:
- English
- Subjects (All):
- Drugs.
- Medical laws and legislation.
- Medicine--Research.
- Medicine.
- Physical Description:
- 1 online resource (38 pages, digital, PDF file)
- Place of Publication:
- [Place of publication not identified] : [publisher not identified], 2010.
- System Details:
- text file
- Summary:
- Report examining FDA use of non-inferiority trial evidence in new drug applications for new molecular entities, and reviewing trial characteristics and FDA guidance.
- Notes:
- Record is based on bibliographic data in ProQuest U.S. Serial Set Digital Collection (last viewed Feb. 2013). Reuse except for individual research requires license from ProQuest, LLC.
- Print.
- Other Format:
- Microfiche version: United States. Government Accountability Office. New Drug Approval
- Access Restriction:
- Restricted for use by site license.
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