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Prescription Drugs: Many Factors Affected FDA’s Approval of Selected “Pipeline” Drugs
Prescription Drugs: Many Factors Affected FDA’s Approval of Selected “Pipeline” Drugs
 
Our Price: $25.00
Year: 2000
Pages: 53
Binding Paperback

Product Code: 0756708095

Description
 
Janet Heinrich (au). Legislation was recently introduced to institute a process by which the manufacturers of pipeline drugs that took longer than 5 years to be approved & whose patents were still in effect could apply for a patent extension. Seven of the 122 pipeline drugs would be eligible for review under this proposal. This report examines FDA review & approval of the manufacturers’ applications to market 7 drugs that would be covered by the proposed legislation. It examined: the review & approval times for the 7 pipeline drugs in comparison with other drugs & the factors that contributed to the time FDA required to approve the 3 of the 7 drugs for which the manufacturers agreed to supply information. Charts & tables.

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