Download or read book Federal Food Drug and Cosmetic Act factory Inspections written by United States. Congress. House. Committee on Interstate and Foreign Commerce and published by . This book was released on 1950 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considers legislation to restore FDA authority to make factory inspections.
Download or read book FDA Factory Inspection Authority Under the Federal Food Drug and Cosmetic Act written by H. Edward Dunkelberger and published by . This book was released on 1978 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Factory Inspection Authority Under the Federal Food Drug and Cosmetic Act written by Covington & Burling (Washington, D.C.) and published by . This book was released on 1987 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food Drug and Cosmetic Act factory Inspections Hearings on H R 2769 H R 3551 and H R 3604 May 19 and 20 1953 written by United States. Congress. House. Committee on Interstate and Foreign Commerce and published by . This book was released on 1953 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food Drug and Cosmetic Act written by United States. Congress. House. Committee on Interstate and Foreign Commerce and published by . This book was released on 1953 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Investigations Operations Manual written by Food and Drug Administration and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book A Legislative History of the Federal Food Drug and Cosmetic Act and Its Amendments written by United States and published by . This book was released on 1979 with total page 1068 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Legislative History of the Federal Food Drug and Cosmetic Act and Its Amendments Text written by and published by . This book was released on 1979 with total page 1076 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Inspection Operations Manual written by United States. Department of Health and Human Services and published by . This book was released on 1983 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Inspection Operations Manual written by and published by . This book was released on 1989 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug Industry Act of 1962 written by United States. Congress. House. Committee on Interstate and Foreign Commerce and published by . This book was released on 1962 with total page 734 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considers the following bills to amend the Federal Food, Drug, and Cosmetic Act. H.R. 11581, the Drug and Factory Inspection Amendments of 1962, to require manufacturers to follow certain research, production and marketing safety procedures. H.R. 11582, the Cosmetics and Therapeutic Devices Amendments of 1962, to require safety certification for cosmetics and medical devices; to require labeling on containers containing hazardous substances; and to strengthen controls on food and animal feed additives.
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Download or read book Food Drug Cosmetic and Device Enforcement Amendments written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1991 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Abstract: This House hearing examines the additional enforcement needed for the requirements of the Federal Food, Drug, and Cosmetic Act. The bill would give the FDA the ability to recall defective and unsafe products, to assess civil penalties, to subpoena witnesses and documents to embargo defective products, and to destroy imported products that pose a danger to public health.
Download or read book A Legislative History of the Federal Food Drug and Cosmetic Act and Its Amendments written by United States and published by . This book was released on 1979 with total page 1284 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food Drug Cosmetic and Device Enforcement Authorities Act written by United States and published by . This book was released on 1992 with total page 149 pages. Available in PDF, EPUB and Kindle. Book excerpt:
