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FDA´s Expedited Drug Programs: Analysis, Postmarket Monitoring & Industry Guidance
Gary Lawrence
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Description for FDA´s Expedited Drug Programs: Analysis, Postmarket Monitoring & Industry Guidance
Paperback. Editor(s): Lawrence, Gary. Num Pages: 100 pages. BIC Classification: MMG. Category: (P) Professional & Vocational. Dimension: 230 x 155. .
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 ... Read more
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 ... Read more
Product Details
Publisher
Nova Science Publishers Inc
Format
Paperback
Publication date
2016
Condition
New
Number of Pages
100
Place of Publication
New York, United States
ISBN
9781634857727
SKU
V9781634857727
Shipping Time
Usually ships in 5 to 9 working days
Ref
99-2
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