Back to Pharmaceuticals: Definition & Lifecycle
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Pharmaceuticals: Definition & Lifecycle

This course covers 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.

1.00 RAC

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Drugs and biologics go through a long and complex process of development before being made available for the treatment or prevention of diseases. This process involves a wide range of experts, including chemists, pharmacists, medical doctors and clinicians as well as professionals in areas such as...

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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