The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceut..
In response to a congressional request, GAO examined the Food and Drug Administration's (FDA): (1) implementation of the premarket notification provision of the Medical Device Amendments of 1976; and (2) day-to-day operations in making its determinati..
It simplifies the complexities involved in getting FDA clearance by using an integrated approach of clinical, engineering, and business aspects. It includes both medical devices and drug development. This involves understanding the structure of the FDA, it..
The goal of this book is to help organizations gain rapid regulatory approval.Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:chronicles the major shifts in inspection activity as evidenced by a systems-based approach..
This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the desi..
This book and its accompanying CD-ROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management.Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceu..
Food and Drug Administration (FDA) data on refusals of food offered for importation into the United States from 1998 to 2004. Although the data do not necessarily reflect the distribution of risk in foods, the study found that import refusals highlight foo..
And Canada) Over 455 Photoguide images of the most popular tablets and capsulesPlus FREE companion Toolkit available online through NDHnow.comMonthly FDA updates on new drugs, indications, and warningsPharmacology videos, audio pronunciation guide, and En..
