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FDA Consumer Special Issue This second edition of the FDA Consumer special issue From Test Tube To Patient: New Drug Development in the United States was published in January 1995. (The first edition was published in May 1993.) An edition published in 1999 by FDA's Center for Drug Evaluation and Research is available on this Website only in PDF format*. Printed copies of the 1999 edition are also available from the Government Printing Office.

 

From Test Tube To Patient:
New Drug Development in the United States
Second Edition
January 1995

Introduction

The Beginnings: Laboratory and Animal Studies

Testing Drugs in People

Drug Testing from a Patient's Perspective

Protecting 'Human Guinea Pigs'

FDA Finds New Ways to Speed Treatments to Patients

Benefit Vs. Risk: How FDA Approves New Drugs

Getting Outside Advice for 'Close Calls'

An Inside Look at FDA On-Site

MedWatch on Lookout for Medical Product Problems

Orphan Products: New Hope for People with Rare Disorders

User Fees to Fund Faster Reviews

FDA Ensures Equivalence of Generic Drugs

Medicines from Space

Why FDA Is Encouraging Drug Testing in Children

* Documents in Portable Document Format (PDF) retain their original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's Website with full installation instructions.

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