Author: Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 35
Book Description
Reinventing Regulation of Drugs and Medical Devices
Author: Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 35
Book Description
Reinventing Regulation of Drugs and Medical Devices
Author: Bill ClintonReinventing the Regulation of Drugs Made from Biotechnology
Author: Bill ClintonPublisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 14
Book Description
Medical Product Regulatory Affairs
Author: John J. TobinPublisher: John Wiley & Sons
ISBN: 3527644717
Category : Science
Languages : en
Pages : 304
Book Description
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Reinventing Drug & Medical Device Regulations, April 1995
Author: The Use of Drugs in Food Animals
Author: National Research CouncilPublisher: National Academies Press
ISBN: 0309175771
Category : Medical
Languages : en
Pages : 276
Book Description
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
Medical Devices Bulletin
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 516
Book Description
Quality Assurance in Dialysis
Author: L.W. HendersonPublisher: Springer Science & Business Media
ISBN: 0585283125
Category : Medical
Languages : en
Pages : 305
Book Description
In examining the preface of our first book, it is increases needed. The Deming philosophy empha apparent that the editorial comments made in sizes that quality is never fully achieved: process 1994 are even more pertinent in today's cost- improvement is never ending. constrained healthcare environment than when But, what is quality? Without defining, David first written. We repeat them in part. Garvin makes the point that "in its original form, This is a time in history when the concept of quality activities were reactive and inspecti- quality is reaching new highs in terms of public oriented; today, quality related activities have awareness. Articles describing quality, CQI, qual broadened and are seen as essential for strategic ity tools, critical success factors, failures, and success" [1]. How can the broad context of quality lessons learned appear in local newspapers, trade be applied to the diverse aspects of ESRD? journals, scientific periodicals, and professional Furthermore, although far from a new concept, publications on a daily basis, yet implementation Continuous Quality Improvement (CQI) has taken of a quality system in many hospital units is its place as a dominant theme in many industries. approached with caution and the basic tenants of CQI is more broadly applicable, both in concept quality systems and CQI continue to be misunder and execution, to service as well as manufacturi- stood. based operations.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 030922408X
Category : Medical
Languages : en
Pages : 366
Book Description
A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Drug Safety Evaluation
Author: Shayne Cox GadPublisher: John Wiley & Sons
ISBN: 0471459291
Category : Medical
Languages : en
Pages : 1020
Book Description
Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.