FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics Books
Product Description
Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of set of laws that can be hard to navigate. Not only are existing set of laws constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field makes new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing set of laws that govern this constantly changing field. The book examines the pertinent aspects of the Federal Food, Drug, and Ornamental Act as they apply to human drug and device development, research, manufacturing, and marketing. It focuses on the new drug approval administer, cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements. Although there are a number of references on these topics, this book is unique in that it is written in a general, simple to read prose style. It presents in rank drawn from a wide range of resources in a single, simple to use format. FDA approval can be a lengthy and pricey administer. In order for a pharmaceutical manufacturer to place a product on the market for human use, a multiphase course of action must be followed. Providing a reference for students, professionals, and especially those who are charged with the day-to-day tasks of assuring regulatory compliance below FDA guidelines, this book demystifies the inner workings of the FDA and allows you to know how it operates with respect to product approval.
Buy Cheap FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics Online
Related posts:
- Prescription Benefits: A Consumer’s Guide to Free and Discount Prescription Drugs
- Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs
- Affairs: A Guide to Working Through the Repercussions of Infidelity
- Prescription Alternatives:Hundreds of Safe, Natural, Prescription-Free Remedies to Restore and Maintain Your Health, Fourth Edition
- The Regulatory Compliance Almanac: A Guide to Good Manufacturing, Clinical, and Laboratory Practices
This book will not teach you RA, but it will provide you a fantastic reference as an RA professional.
Rating: 5 / 5
Best Available Book for Regulatory Affiars, November 22, 2006
Reviewer: H. Burgoyne (Watertown, MA United States) – See all my reviews
I am now completing a Masters in Regulatory Affairs and throughout all of my classes, this has been the best source (other than the FDA website, which is most current) pertaining to US reg. affairs. Forget any Parexel books…this one really has an index, making it simple to find the in rank you need. Not sure about medical devices, as I do not specialize in them, but for pharmaceuticals and biologics this book is pretty comprehensive. You are not going to get a more “layman’s level” interpretation of set of laws than this book. Set of laws are part of the law, which is never simple to “translate”. It is hard to incorporate set of laws into a book , as they are constantly being updated, but this book does a pretty excellent job. I have used the book to develop presentations, study for exams and write papers. If you are interested in US Regulatory Affairs, this book is certainly worth the investment. The price seems high, but is comparable to other books with the same theme matter.
Rating: 5 / 5
Frequently this book covers (perhaps adequately) FDA regulation of the development and approval administer of new drugs. These new drugs are (by and large) developed by huge drug companies who doubtless use teams of lawyers in connection with their FDA submissions and regulatory compliance, and it is quite likely that near all caught up in that administer with such companies would find this to be a “lite” description of FDA drug set of laws, and will have small use for this book. (Presume a beer having only 10 calories, not the 90 or so found in Miller Lite.)
Many medical devices, on the other hand, are developed by small companies (such as my employer) and a “layman’s level” description (as different to a legal treatise) of FDA medical device regulation would be very helpful. Since “medical device” is in the title, I figured when buying this book that there would be coverage relating to all FDA set of laws pertaining to medical devices. Its why I (or thankfully, my company) bought the book.
Ther coverage of medical devices is grossly inadequate. Only a small part of the book treats (again “litely”) FDA medical device regulation, and then it largely covers only the premarket approval administer for medical devices and barely mentions (or doesn’t even mention–I forget) FDA regulation of the manner in which medical devices may be distributed in the US.
Given the relatively high cost of this book, I expected more and was quite disappointed.
Rating: 2 / 5