Generic Drug Product Development

Generic Drug Product Development
Author: Isadore Kanfer
Publisher: CRC Press
Total Pages: 334
Release: 2016-04-19
Genre: Medical
ISBN: 1420020021

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

Approved Drug Products with Therapeutic Evaluations

Approved Drug Products with Therapeutic Evaluations
Author: DIANE Publishing Company
Publisher: DIANE Publishing
Total Pages: 740
Release: 1995-09
Genre: Medical
ISBN: 9780788104053

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Act; & products that have never been marketed, have been discontinued from marketing, or that have had their approvals withdrawn for other than safety or efficacy reasons.

FDA Investigations Operations Manual

FDA Investigations Operations Manual
Author: Food and Drug Administration
Publisher:
Total Pages: 0
Release: 2003
Genre: Drugs
ISBN: 9780865879737

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.

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
Author: Eunjoo Pacifici
Publisher: Academic Press
Total Pages: 292
Release: 2018-06-13
Genre: Medical
ISBN: 0128111569

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

Generic Animal Drugs

Generic Animal Drugs
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher:
Total Pages: 180
Release: 1987
Genre: Drugs
ISBN:

Generic Drug Product Development

Generic Drug Product Development
Author: Leon Shargel
Publisher: CRC Press
Total Pages: 384
Release: 2013-10-24
Genre: Medical
ISBN: 1420086367

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral

Approved Drug Products with Therapeutic Equivalence Evaluations

Approved Drug Products with Therapeutic Equivalence Evaluations
Author: Barry Leonard
Publisher: DIANE Publishing
Total Pages: 829
Release: 1999-04
Genre:
ISBN: 0788173243

Identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products.