Development of FDA-regulated medical products : prescription drugs, biologics, and medical devices /
By: Whitmore, Elaine.
Contributor(s): Food and Drugs Administration [FDA].
Publisher: Milwaukee, Wis. : ASQ Quality Press, 2004Edition: 2nd ed.Description: xx, 202 p. : ill. ; 23 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 0873896130(hbk. : alk. paper); 9780873896139; 9780873896139(hbk. : alk. paper).Subject(s): United States. Food and Drug Administration | Drug and Narcotic Control -- legislation & jurisprudence -- United States | Drug approval -- United States | Biological Products -- legislation & jurisprudence -- United States | New products -- Standards -- United StatesDDC classification: 615.19Item type | Current library | Call number | Copy number | Status | Date due | Barcode | Item holds |
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Standard Loan | ATU Sligo Yeats Library Main Lending Collection | 615.19 WHI (Browse shelf(Opens below)) | 1 | Available | 0092715 | ||
Standard Loan | ATU Sligo Yeats Library Main Lending Collection | 615.19 WHI (Browse shelf(Opens below)) | 2 | Available | 0092716 | ||
Standard Loan | ATU Sligo Yeats Library Main Lending Collection | 615.19 WHI (Browse shelf(Opens below)) | 3 | Available | 0092713 | ||
Standard Loan | ATU Sligo Yeats Library Main Lending Collection | 615.19 WHI (Browse shelf(Opens below)) | 4 | Available | 0092714 | ||
Standard Loan | ATU Sligo Yeats Library Main Lending Collection | 615.19 WHI (Browse shelf(Opens below)) | 5 | Available | 0092712 |
Includes bibliographical references and index.
List of figures and tables -- Foreword -- Preface -- Preface to previous edition -- Abbreviations -- Part I : unique challenges in medical product development. Chapter 1 : healthcare in the United States. Chapter 2 : it's not your father's FDA : the "modernization" of medical product regulation. Chapter 3 : product liability and product development -- Part II : bringing a new medical product to market. Chapter 4 : overview of the approval processes for drugs, biologics, and medical devices. Chapter 5 : designing-in quality. Chapter 6 : designing-out disaster : risk analysis. Chapter 7 : recalls, revocations, and withdrawals. Chapter 8 : human factors and the nature of relationships : minimizing medical errors. Chapter 9 : is it safe and does it work? Evaluating safety and efficacy in clinical trials. Chapter 10 : how much is the product really worth? Outcomes research, pharmacoeconomics, and managed care -- Part III : product development planning. Chapter 11 : models and metaphors : product development and the product development organization. Chapter 12 : components of product development planning : the product development process. Chapter 13 : components of product development planning : development portfolio management. Chapter 14 : components of product development planning : technology assessment. Chapter 15 : components of product development planning : technology forecasting. Chapter 16 : more for the laundry list : marketing, patents, budgets, games, and quality. Chapter 17 : where do we go from here? -- Endnotes -- Glossary -- Resources -- Index.
Previously published under the title: Product development planning for health care products regulated by the FDA.