Document Detail


Implications of the Lannett and Pharmadyne decisions.
MedLine Citation:
PMID:  7377217     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Lannett (United States v. Articles of Drug) and Pharmadyne (Pharmadyne Laboratories, Inc. v. Kennedy) court decisions are explained and their implications regarding premarket approval of drugs are discussed. The Lannett decision has led to confusion over whether FDA premarketing approval is required for products containing drugs recognized as safe and effective. The Lannett decision has no binding legal effect. Premarketing clearance must be obtained by all drug manufacturers, including the producers of generics.
Authors:
A J Vetrano
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  American journal of hospital pharmacy     Volume:  37     ISSN:  0002-9289     ISO Abbreviation:  Am J Hosp Pharm     Publication Date:  1980 Apr 
Date Detail:
Created Date:  1980-07-12     Completed Date:  1980-07-12     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  0370474     Medline TA:  Am J Hosp Pharm     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  537-40     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Drug Industry*
Jurisprudence*
Legislation, Drug
Therapeutic Equivalency
United States
United States Food and Drug Administration / legislation & jurisprudence*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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