FDA Investigations Operations Manual


Book Description

Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.




Enhancing Food Safety


Book Description

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.










U.S. Inspectors General


Book Description

A 2020 CHOICE Outstanding Academic Title How officials reporting to both executive officials and congressional representatives work to keep the government honest, efficient, and effective. Inspectors general are important players in the federal government, and their work often draws considerable public attention when one of them uncovers serious misdeeds or mismanagement that make the headlines. This book by two experts in public policy provides a comprehensive, up-to-date examination of how inspectors general have operated in the four decades since Congress established the offices to investigate waste, fraud, and mismanagement at federal agencies and to promote efficiency and effectiveness in government programs. Unique among federal officials, inspectors general are independent of the agencies they monitor, and they report to the executive and legislative branches of government. One key factor in their independence is that they are expected to be non-partisan and carry out their work without regard to partisan interests. The authors of U.S. Inspectors General: Truth Tellers in Turbulent Times emphasize the “strategic environment” in which inspectors general work and interact with a variety of stakeholders, inside and outside the government. Their new book is based on in-depth case studies, a survey of inspectors general, and a review of public documents related to the work of inspectors general. It will be of interest to scholars and students of public policy and public management, journalists, and ordinary citizens interested in how the government works—or doesn’t work—on their behalf.







MIS users' manual


Book Description







Medicolegal Death Investigation System


Book Description

The US Department of Justice's National Institute of Justice (NIJ) asked the Institute of Medicine (IOM) of The National Academies to conduct a workshop that would examine the interface of the medicolegal death investigation system and the criminal justice system. NIJ was particularly interested in a workshop in which speakers would highlight not only the status and needs of the medicolegal death investigation system as currently administered by medical examiners and coroners but also its potential to meet emerging issues facing contemporary society in America. Additionally, the workshop was to highlight priority areas for a potential IOM study on this topic. To achieve those goals, IOM constituted the Committee for the Workshop on the Medicolegal Death Investigation System, which developed a workshop that focused on the role of the medical examiner and coroner death investigation system and its promise for improving both the criminal justice system and the public health and health care systems, and their ability to respond to terrorist threats and events. Six panels were formed to highlight different aspects of the medicolegal death investigation system, including ways to improve it and expand it beyond its traditional response and meet growing demands and challenges. This report summarizes the Workshop presentations and discussions that followed them.