Document Detail

Administrative practices and procedures; internal review of agency decisions---FDA. Direct final rule.
MedLine Citation:
PMID:  10180278     Owner:  NLM     Status:  MEDLINE    
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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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Jun 
Date Detail:
Created Date:  1998-07-17     Completed Date:  1998-07-17     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  32733-5     Citation Subset:  H    
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MeSH Terms
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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