FDA, Inside & Out

Download or read book FDA, Inside & Out written by Suzanne Parisian and published by . This book was released on 2001 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parisian (formerly of the Food and Drug Administration, now a consultant) offers a guide to preparing clinical trials intended for submission to the FDA and for marketing purposes. She also provides an organizational map of the agency, outlining its requirements, procedures, and history, with an emphasis on the implications for medical practice, manufacturing, and marketing. The logic governing the agency and the rationale by which it makes its decisions are included in the coverage. Annotation copyrighted by Book News Inc., Portland, OR.