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FDA Drug Approval: Elements & Considerations

FDA Drug Approval: Elements & Considerations

9781622570911
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Description
The Food and Drug Administration (FDA) oversees the approval and regulation of drugs entering the U.S. market. Two regulatory frameworks support the FDAs 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 FDAs role in that process and the FDA and industry roles once drugs are on pharmacy shelves.
Product Details
Nova Science Publishers Inc
73950
9781622570911
9781622570911

Data sheet

Publication date
2012
Issue number
1
Cover
hard cover
Pages count
142
Dimensions (mm)
155.00 x 230.00
Weight (g)
358
  • Preface; How FDA Approves Drugs and Regulates their Safety & Effectiveness; Inside Clinical Trials:: Testing Medical Products in People; New Drug Approval:: FDAs Consideration of Evidence from Certain Clinical Trials; New Drug Approval:: FDA Needs to Enhance its Oversight of Drugs Approved on the Basis of Surrogate Endpoints; Index.
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