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FDA regulatory affairs : a guide for prescription drugs, medical devices and biologics /

Pisano, Douglas J.

FDA regulatory affairs : a guide for prescription drugs, medical devices and biologics / - Boca Raton, Fla. ; London : CRC, 2003. - 250 p. ; 23 cm.

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.

1587160072 9781587160073 : £32.99


United States. Food and Drug Administration --Rules and practice.


Drugs--Testing.--United States
Drug development--United States.
Pharmaceutical industry--United States.
Medical instruments and apparatus--United States.

615.190973 / PIS