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e-Book: Fundamentals of US Regulatory Affairs, Eighth Edition

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e-Book: Fundamentals of US Regulatory Affairs, Eighth Edition

The e-book format of Fundamentals of US Regulatory Affairs, Eighth Edition is fully searchable and easy to navigate. It is a secure PDF, compatible with most tablets. Note: You may need to download an app for your specific device.

The new Fundamentals of US Regulatory Affairs, Eighth Edition is the only book of its kind, covering the most current regulatory requirements for the US Food and Drug Administration and other state and federal agencies. The comprehensive, yet easy-to-understand text is a trusted compilation of information and analysis from 42 regulatory experts. The next time you are unsure about a regulation, are working on an unfamiliar product line or need to brush up on new areas, reach for the book for regulatory professionals. It will save you time and help you make better regulatory decisions.

» View the Table of Contents

Who should use this publication?

Fundamentals is designed to be a reference resource for regulatory professionals at all levels—from those new to the field or preparing for the US RAC exam, to senior management looking for a quick fact.

Special Offer

Get both the paperback and e-book versions for $60 more when you select the bundled option.

The Fundamentals of Regulatory Affairs series is available for a number of regions, including:

Copyright 2013, RAPS

Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design

Section II: Drugs
Chapter 11 Prescription Drug Submissions
Chapter 12 Postapproval Prescription Drug Submissions and Compliance
Chapter 13 Generic Drug Submissions
Chapter 14 Patents and Exclusivity
Chapter 15 Over-the-Counter Drug Products
Chapter 16 Prescription Drug Labeling, Advertising and Promotion
Chapter 17 Pharmacovigilance

Section III: Medical Devices
Chapter 18 Medical Device Submissions
Chapter 19 Medical Device Compliance and Postmarketing Activities
Chapter 20 Advertising, Promotion and Labeling for Medical Devices and IVDs
Chapter 21 In Vitro Diagnostics Submissions and Compliance

Section IV: Biologics
Chapter 22 Biologics Submissions
Chapter 23 Biologics Compliance
Chapter 24 Biologics Labeling, Advertising and Promotion

Section V: Other Product Classifications
Chapter 25 Combination Products
Chapter 26 Regulation of Products for Small Patient Populations
Chapter 27 Blood and Blood Products
Chapter 28 Human Cell and Tissue Products
Chapter 29 Regulations Pertaining to Pediatrics
Chapter 30 Dietary Supplements and Homeopathic Products
Chapter 31 Cosmetics
Chapter 32 Veterinary Products
Chapter 33 Food Products
Chapter 34 Companion Diagnostics
Chapter 35 Medical Foods

Section VI: Inspection and Enforcement
Chapter 36 FDA Inspection and Enforcement
Chapter 37 Healthcare Fraud and Abuse Compliance

Section VII: Resources
Chapter 38 Regulation Information Resources in Review

Appendices
Comparative Matrix of Regulations Across Product Lines
Glossary of Terms
Index


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