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Re: drkazmd65 post# 68441

Monday, 06/03/2013 1:47:49 PM

Monday, June 03, 2013 1:47:49 PM

Post# of 146240
Yes, and from the FDA website:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm


Fast Track, Accelerated Approval and Priority Review
Accelerating Availability of New Drugs for Patients with Serious Diseases
Speeding the development and availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or have advantages over existing treatments. The Food and Drug Administration (FDA) has developed three distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.

The following summary describes each element, how they differ, and how they complement each other.

Fast Track
Accelerated Approval
Priority Review
Comparison of Approval Times for Priority and Standard Review Drugs between 1993 and 2003



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