FDA Drug Approval : Elements & Considerations

Timothy I King

ISBN 10: 162257091X / ISBN 13: 9781622570911

Published by Nova Science Publishers Inc Okt 2012, 2012

About this Item

Neuware - 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.

Seller Inventory # 9781622570911

Bibliographic Details

• Title: FDA Drug Approval : Elements & Considerations
• Publisher: Nova Science Publishers Inc Okt 2012
• Publication Date: 2012
• Language: English
• ISBN 10: 162257091X
• ISBN 13: 9781622570911
• Binding: Buch
• Condition: Neu
• Dimensions: 237W x 171H x 13D millimeters 237 millimeters width by 171 millimeters height by 13 millimeters depth
• Weight: 352 grams

About this title

Synopsis

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.