FDA Drug Approval : Elements & Considerations
Book Details
Format
Hardback or Cased Book
ISBN-10
162257091X
ISBN-13
9781622570911
Publisher
Nova Science Publishers Inc
Imprint
Nova Science Publishers Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Oct 5th, 2012
Print length
142 Pages
Weight
352 grams
Dimensions
23.70 x 17.10 x 1.30 cms
Product Classification:
Pharmacology
Ksh 28,800.00
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The Food and Drug Administration (FDA) oversees the approval and regulation of drugs entering the U.S. market. Two regulatory frameworks support the FDA''s review of prescription drugs. First, FDA reviews the safety and effectiveness of new drugs that manufacturers wish to market in the United States; this process is called pre-market approval or pre-approval review. Second, once a drug has passed that threshold and is FDA-approved, FDA acts through its post-market or post-approval regulatory procedures. This book is a primer on drug approval and regulation. It describes how drugs are approved and come to market, including the FDA''s role in that process and the FDA and industry roles once drugs are on pharmacy shelves.
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