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The French Drug Approval Process II: The Clinical Basis for Negative Decisions by the Commission for Authorization of Marketing a Medication
Author(s) -
Weintraub Michael
Publication year - 1985
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1985.tb02819.x
Subject(s) - marketing authorization , clinical trial , commission , authorization , denial , government (linguistics) , medicine , drug approval , business , drug , marketing , pharmacology , psychology , finance , computer security , pathology , bioinformatics , linguistics , philosophy , computer science , psychoanalysis , biology
Between 1982 and 1983, the Commission on Approval for Marketing Medications of the French government made 76 negative decisions based on problems with clinical trials. In 21 instances, the reasons for a temporary negative decision could be resolved from data already on hand or readily available. More serious problems resulted in requests for new studies having better controls, better management of ancillary therapy, more participants, or lasting longer. Indications that denial of the application is likely or outright refusals to grant approval were based on failure to demonstrate efficacy and concerns about toxicity. Analysis of the reasons for negative decisions can ameliorate the clinical trials submitted in support of an application for marketing approval. Improving the design and conduct of clinical trials based on correcting the defects discussed here would benefit the sciences of drug development, regulation, and patient care.