FDA's Expedited Drug Programs : Analysis, Postmarket Monitoring & Industry Guidance
Book Details
Format
Paperback / Softback
ISBN-10
1634857720
ISBN-13
9781634857727
Publisher
Nova Science Publishers Inc
Imprint
Nova Science Publishers Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Sep 1st, 2016
Print length
100 Pages
Weight
186 grams
Dimensions
23.30 x 15.50 x 0.90 cms
Product Classification:
Pharmacology
Ksh 20,900.00
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The Food and Drug Administration (FDA) oversees the safety and effectiveness of drugs sold on the U.S. market. When there is an unmet need for the treatment of a serious condition, FDA may use one or more of its expedited programs, such as fast track and breakthrough therapy designation, which are intended to bring drugs to market more quickly. FDA is also responsible for monitoring the safety of drugs and reporting on those efforts. This book examines the number and types of requests for fast track or breakthrough therapy designation; the number and types of FDA-approved drug applications that used an expedited program; and the extent to which FDAs data on tracked safety issues and postmarket studies allowed the agency to meet its reporting and oversight responsibilities.
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