FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics|
by Douglas J. Pisano (Editor), David Mantus (Editor)
This book covers the regulatory process for getting pharmaceuticals, biologics,
and medical devices approved. 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. Topics include: the drug approval
process, Current Good Manufacturing Practices, Good Clinical Practices, Quality
System Compliance and the corresponding documentation requirements, and FDA
inspection processes and enforcement options. Although many references exist on
this subject, this one is written in a general prose style that makes it useful
to both students and professionals.
Massachusetts College of Pharmacy and Health Sciences, Worcester. Provides a
road map to the FDA and drug, biologic, and medical device developoment.
Highlights the new drug application process and discusses FDA inspection
processes and enforcement options. Features contributions by experts from
leading pharmaceutical companies. Clear, concise format. Softcover.
Paperback: 360 pages
Publisher: Informa Healthcare; 1 edition (December 23, 2003)