Regional Regulations - US

From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories
Available

From quack medical devices that supposedly heal with mysterious powers, to the role luck and intuition have played in discovering some of our most effective and widely used drugs, Max Sherman’s From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories is a fascinating and intriguing exploration of the quirky side of science.

Fundamentals of US Regulatory Affairs, Seventh Edition Bundle
Available
This highly acclaimed RAPS publication is the perfect reference tool for any regulatory professional working in the US market. Bundle includes hard copy and e-book. Buy together and save!

On-demand Webcast: Healthcare Reform & Comparative Effectiveness Research: Essential Know-How
Available
A recording of the RAPS Webcast on healthcare reform and comparitive effectiveness research, originally recorded 10 June 2010.

Good Laboratory Practice Regulations
Available
Provides a guide to good laboratory management and an analysis of GLP requirements.

FDA Regulatory Affairs
Available
This book 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.

Pharmaceuticals: US Regulations
Available

This course provides an overview of the history of pharmaceuticals in the US, the requirements to obtain prescription (Rx) and over-the-counter (OTC) drug approvals, and other requirements that are in place to ensure compliance with US Food and Drug Administration (FDA) regulations, such as pharmacovigilance reporting.

US Regulations Bundle: Pharmaceuticals Focus
Purchase Fundamentals of US Regulatory Affairs, Seventh Edition, FDA: A History, US Regulatory Acronyms & Definitions, FDA Regulatory Affairs and Pharmaceuticals: US Regulations together and save on these indespensable reference tools, our most popular products to help you learn the pharmaceutical side of the US regulatory landscape.

Medical Devices: US Regulations
Available
This course covers a wide range of issues, from the history of medical device regulation through the steps required to submit an application to the Food and Drug Administration (FDA) for approval to market a device through postmarket requirements. This course also discusses device classification as well as electing the appropriate FDA application for the device, including labeling, establishment registration and listing.

Fundamentals of US Regulatory Affairs, Seventh Edition
Available
This highly acclaimed publication is the perfect reference tool for any US regulatory affairs professional.

Prosecuting and Defending Health Care Fraud Cases
Available
This book, written by two experienced practitioners, guides you through difficult medical, regulatory, and law enforcement issues.

The FDA Advisory Committee Survival Manual
Available
This book that provides all the tools you need to strategize and prepare for an advisory committee hearing.

Life Sciences Law: Federal Regulation
Available
An updated and expanded comprehensive analysis of food and drug law topics and the federal agencies that regulate this burgeoning industry.

US Regulations Bundle: Device and Pharmaceuticals
Purchase Fundamentals of US Regulatory Affairs, Seventh Edition, FDA: A History, US Regulatory Acronyms & Definitions, FDA Regulatory Affairs, Medical Device: US Regulations and Pharmaceuticals: US Regulations together and save on these indespensable reference tools, our most popular and comprehensive set of products to help you learn the US regulatory landscape.

US Regulations Bundle: General
Available
Purchase Fundamentals of US Regulatory Affairs, Seventh Edition, FDA: A History, US Regulatory Acronyms & Definitions and FDA Regulatory Affairs together and save on these indespensable reference tools, our most popular products to help you learn the US regulatory landscape.

US Regulatory Acronyms & Definitions Pocket Guide, Fourth Edition
Available
A pocket guide covering terms and definitions most commonly used by U.S. regulatory professionals.

FDA: A History
Available
This DVD provides a comprehensive look at the history of the U.S. Food and Drug Administration. 

US Regulations Bundle: Device Focus
Purchase Fundamentals of US Regulatory Affairs, Seventh Edition, FDA: A History, US Regulatory Acronyms & Definitions, FDA Regulatory Affairs and Medical Devices: US Regulations together and save on these indespensable reference tools, our most popular products to help you learn the medical device side of the US regulatory landscape.