Author: National Institutes of Health (U.S.). Division of Biologics Standards
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 20

Get Book Here

Book Description

Author: Mark P. Mathieu
Publisher: Parexel International Corporation
ISBN:
Category : Political Science
Languages : en
Pages : 328

Get Book Here

Book Description

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309175321
Category : Medical
Languages : en
Pages : 137

Get Book Here

Book Description
This volume examines regulatory and policymaking procedures in blood banking, regulatory enforcement and compliance, innovations and alternatives in regulation, congressional oversight and regulatory initiatives, and investment in regulatory quality.

Author: Eunjoo Pacifici
Publisher: Academic Press
ISBN: 0128111569
Category : Medical
Languages : en
Pages : 292

Get Book Here

Book Description
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

Author: United States. Food and Drug Administration. Bureau of Biologics
Publisher:
ISBN:
Category :
Languages : en
Pages : 48

Get Book Here

Book Description

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442

Get Book Here

Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432

Get Book Here

Book Description
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Author: National Institutes of Health (U.S.)
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 124

Get Book Here

Book Description

Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28

Get Book Here

Book Description

Author: Douglas J. Pisano
Publisher: CRC Press
ISBN: 1040061974
Category : Medical
Languages : en
Pages : 466

Get Book Here

Book Description
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in