FDA regulatory affairs : a guide for prescription drugs, medical devices and biologics /
By: Pisano, Douglas J
.
Publisher: Boca Raton, Fla. ; London : CRC, 2003Description: 250 p. ; 23 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 1587160072; 9781587160073 :.Subject(s): United States. Food and Drug Administration -- Rules and practice | Drugs -- United States -- Testing | Drug development -- United States | Pharmaceutical industry -- United States | Medical instruments and apparatus -- United StatesDDC classification: 615.190973 Summary: This text covers the regulatory requirements of pharmaceuticals, biologics, and medical devices. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing.
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This text covers the regulatory requirements of pharmaceuticals, biologics, and medical devices. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing.