| Administrative practices and procedures; internal review of agency decisions---FDA. Direct final rule. | |
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MedLine Citation:
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PMID: 10180278 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is amending its regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. This action is being taken to clarify the availability of review of scientific controversies by such advisory panels and committees. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule. If any significant adverse comment is received, FDA will withdraw the direct final rule and will follow its usual procedures for notice-and-comment rulemaking based on the companion proposed rule. |
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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 Jun |
Date Detail:
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Created Date: 1998-07-17 Completed Date: 1998-07-17 Revised Date: 2000-12-18 |
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: 32733-5 Citation Subset: H |
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| MeSH Terms | |
Descriptor/Qualifier:
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Decision Making, Organizational Device Approval / legislation & jurisprudence* Drug Approval / legislation & jurisprudence* Peer Review / legislation & jurisprudence* United States United States Food and Drug Administration / organization & administration |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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