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Compassionate Use & Emergency Use Authorization for Unapproved Drugs: FDA Policies & Background
Tonya Burke
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Description for Compassionate Use & Emergency Use Authorization for Unapproved Drugs: FDA Policies & Background
Hardback. Editor(s): Burke, Tonya. Num Pages: 95 pages. BIC Classification: MMG. Category: (P) Professional & Vocational. Dimension: 230 x 155. .
The Food and Drug Administration (FDA) regulates the U.S. sale of drugs and biological products, basing approval or licensure on evidence of the safety and effectiveness for a product's intended uses. Without that approval or licensure, a manufacturer may not distribute the product except for use in the clinical trials that will provide evidence to determine that product's safety and effectiveness. Under certain circumstances, however, FDA may permit the sponsor to provide an unapproved or unlicensed product to patients outside that standard regulatory framework. Two such mechanisms are expanded access to investigational drugs, commonly referred to as compassionate use, and ... Read more
The Food and Drug Administration (FDA) regulates the U.S. sale of drugs and biological products, basing approval or licensure on evidence of the safety and effectiveness for a product's intended uses. Without that approval or licensure, a manufacturer may not distribute the product except for use in the clinical trials that will provide evidence to determine that product's safety and effectiveness. Under certain circumstances, however, FDA may permit the sponsor to provide an unapproved or unlicensed product to patients outside that standard regulatory framework. Two such mechanisms are expanded access to investigational drugs, commonly referred to as compassionate use, and ... Read more
Product Details
Publisher
Nova Science Publishers Inc
Format
Hardback
Publication date
2016
Condition
New
Number of Pages
95
Place of Publication
New York, United States
ISBN
9781634841320
SKU
V9781634841320
Shipping Time
Usually ships in 5 to 9 working days
Ref
99-2
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