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Compassionate use & emergency use authorization for unapproved drugs

by Tonya Burke | 01 January 2016
Category: Medical Academic
The Food and Drug Administration (FDA) regulates the U.S. sale of drugs and biological products, basing approval or licensure on evidence of the safety and effectiveness for a product's intended uses. Without that approval or licensure, a manufacturer may not distribute the product except for use in the clinical trials that will provide evidence to determine that product's safety and effectiveness. Under certain circumstances, however, FDA may permit the sponsor to provide an unapproved or unlicensed product to patients outside that standard regulatory framework. Two such mechanisms are expanded access to investigational drugs, commonly referred to as compassionate use, and emergency use authorisation. This book examines FDA policies on compassionate use and emergency use authorisations. It also describes how drugs are approved and come to market, including FDA's role in that process, and discusses FDA and industry roles once drugs are on the pharmacy shelves. Finally, this book describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary; presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children, and provides an overall understanding of FDA's authority to ensure that drugs prescribed to children are safe and effective.
€159.60
478 Reward Points
In stock online
Delivery 5-7 Days
Eligible for free delivery

Any purchases for more than €10 are eligible for free delivery anywhere in the UK or Ireland!

The Food and Drug Administration (FDA) regulates the U.S. sale of drugs and biological products, basing approval or licensure on evidence of the safety and effectiveness for a product's intended uses. Without that approval or licensure, a manufacturer may not distribute the product except for use in the clinical trials that will provide evidence to determine that product's safety and effectiveness. Under certain circumstances, however, FDA may permit the sponsor to provide an unapproved or unlicensed product to patients outside that standard regulatory framework. Two such mechanisms are expanded access to investigational drugs, commonly referred to as compassionate use, and emergency use authorisation. This book examines FDA policies on compassionate use and emergency use authorisations. It also describes how drugs are approved and come to market, including FDA's role in that process, and discusses FDA and industry roles once drugs are on the pharmacy shelves. Finally, this book describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary; presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children, and provides an overall understanding of FDA's authority to ensure that drugs prescribed to children are safe and effective.
Quantity:
In stock online
Delivery 5-7 Days
Eligible for free delivery
478 Reward Points

Any purchases for more than €10 are eligible for free delivery anywhere in the UK or Ireland!

€159.60
In stock online
Delivery 5-7 Days
Eligible for free delivery
Quantity:
478 Reward Points

Any purchases for more than €10 are eligible for free delivery anywhere in the UK or Ireland!

Product Description

The Food and Drug Administration (FDA) regulates the U.S. sale of drugs and biological products, basing approval or licensure on evidence of the safety and effectiveness for a product's intended uses. Without that approval or licensure, a manufacturer may not distribute the product except for use in the clinical trials that will provide evidence to determine that product's safety and effectiveness. Under certain circumstances, however, FDA may permit the sponsor to provide an unapproved or unlicensed product to patients outside that standard regulatory framework. Two such mechanisms are expanded access to investigational drugs, commonly referred to as compassionate use, and emergency use authorisation. This book examines FDA policies on compassionate use and emergency use authorisations. It also describes how drugs are approved and come to market, including FDA's role in that process, and discusses FDA and industry roles once drugs are on the pharmacy shelves. Finally, this book describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary; presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children, and provides an overall understanding of FDA's authority to ensure that drugs prescribed to children are safe and effective.

Product Details

Compassionate use & emergency use authorization for unapproved drugs

ISBN9781634841320

Format

Publisher (01 January. 2016)

No. of Pages95

Weight292

Language English (United States)

Dimensions 230 x 155 x 12