Author:
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144
Book Description
FDA Approved Animal Drug Products
Author:
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144
Book Description
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144
Book Description
Approved Prescription Drug Products
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 40
Book Description
Accompanied by supplements.
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 40
Book Description
Accompanied by supplements.
Drug Safety
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 12
Book Description
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 12
Book Description
An Overview of FDA Regulated Products
Author: Eunjoo Pacifici
Publisher: Academic Press
ISBN: 0128111569
Category : Medical
Languages : en
Pages : 292
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
Publisher: Academic Press
ISBN: 0128111569
Category : Medical
Languages : en
Pages : 292
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
Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
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.
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
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.
Approved Drug Products with Therapeutic Evaluations
Author: DIANE Publishing Company
Publisher: DIANE Publishing
ISBN: 9780788104053
Category : Medical
Languages : en
Pages : 740
Book Description
Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Composed of 4 parts: approved prescription drug products with therapeutic equivalence evaluations; over-the-counter (OTC) drug products that require approved applications as a condition of marketing; drug products with approval under Sect. 505 of the Act; & products that have never been marketed, have been discontinued from marketing, or that have had their approvals withdrawn for other than safety or efficacy reasons.
Publisher: DIANE Publishing
ISBN: 9780788104053
Category : Medical
Languages : en
Pages : 740
Book Description
Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Composed of 4 parts: approved prescription drug products with therapeutic equivalence evaluations; over-the-counter (OTC) drug products that require approved applications as a condition of marketing; drug products with approval under Sect. 505 of the Act; & products that have never been marketed, have been discontinued from marketing, or that have had their approvals withdrawn for other than safety or efficacy reasons.
Generic drug entry prior to patent expiration an FTC study
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Book Description
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
Book Description
Generic Animal Drugs
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 180
Book Description
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 180
Book Description
Medical Countermeasures Dispensing
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309186501
Category : Medical
Languages : en
Pages : 95
Book Description
During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.
Publisher: National Academies Press
ISBN: 0309186501
Category : Medical
Languages : en
Pages : 95
Book Description
During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.
Generic Drug Product Development
Author: Isadore Kanfer
Publisher: CRC Press
ISBN: 1420020021
Category : Medical
Languages : en
Pages : 334
Book Description
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica
Publisher: CRC Press
ISBN: 1420020021
Category : Medical
Languages : en
Pages : 334
Book Description
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica