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Prescription Drugs Many Factors Affected Fda's Approval of Selected "Pipeline" Drugs

Author: 


ISBN-13: 

9780756708092


ISBN: 

0756708095


Publisher:  DIANE Publishing Company
Summary: Legislation was recently introduced to institute a process by which the manufacturers of pipeline drugs (PD) that took longer than 5 years to be approved & whose patents were still in effect could apply for a patent extension. 7 of the 122 PD would be eligible for review under this proposal. This report examines FDA review & approval (R&A) of the manufacturers' applications to market 7 drugs that would be covered by ...the proposed legislation. It examined: the R&A times for the 7 PD 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.

Heinrich, Janet is the author of Prescription Drugs Many Factors Affected Fda's Approval of Selected "Pipeline" Drugs, published under ISBN 9780756708092 and 0756708095. One hundred Prescription Drugs Many Factors Affected Fda's Approval of Selected "Pipeline" Drugs textbooks are available for sale on ValoreBooks.com, or buy new starting at $24.41.
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ISBN-13: 9780756708092


ISBN: 0756708095


Publisher: DIANE Publishing Company
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