| Public information; communications with state and foreign government officials--FDA. Proposed rule. | |
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MedLine Citation:
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PMID: 10181518 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is proposing to amend its regulations governing communications with State and foreign government officials. The proposed rule would permit FDA to disclose confidential commercial information to international organizations having responsibility to facilitate global or regional harmonization of standards and requirements. These disclosures would, in almost all instances, occur only with the consent of the person providing the confidential commercial information to FDA. The proposed rule would also streamline the process for FDA officials to disclose certain nonpublic, predecisional documents (such as draft rules and guidance documents) to State and foreign government officials. The proposal does not alter current procedures for sharing documents that contain confidential commercial information. These changes are intended to facilitate information exchanges with State and foreign governments and certain international organizations. |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 63 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 1998 Jul |
Date Detail:
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Created Date: 1998-09-03 Completed Date: 1998-09-03 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 40069-72 Citation Subset: H |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Device Approval
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standards* Equipment and Supplies / standards* Humans Information Services / legislation & jurisprudence* International Cooperation* United States United States Food and Drug Administration |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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