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FDA Proposes New “Off‐Label” Information Dissemination Rules

 

作者:

 

期刊: Biomedical Safety & Standards  （OVID Available online 1998）
卷期: Volume 28, issue 12  

页码: 93-93

 

ISSN:1080-9175

 

年代: 1998

 

出版商: OVID

 

数据来源: OVID

 

摘要:

Under the proposal, the “greater flexibility” to disseminate information only applies to discussions of off-label uses of already approved products and then only if the uses have been, or will be, studied and submitted for FDA approval.

 

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