Amarantus Bioscience Holdings Inc (AMBS)

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Approval Times for Drugs

ORPHAN Drugs - Time line
Standard approval times for branded drugs are six to 10 months.

Under the Prescription Drug User Fee Act, drugs are reviewed by:

• Standard Review, which is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The goal is that a Standard Review of a new drug application be accomplished within a ten-month time frame.
• Priority Review, which is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The goal is to complete a Priority Review is six months. Priority Review status applies to drugs that are used to treat serious diseases and drugs for less serious illnesses.

Generic drug applications are reviewed in a "first in, first out" order, with the exception of a few types of applications, such as first-time generics and AIDS drugs under PEPFAR. There are not set goals for review times.

Currently generic drug applications are taking about 20 months to review due to a backlog of a high volume of applications.

http://pharmacy.about.com/od/TheDrugIndustry/a/The-Fda-Drug-Approval-Process.htm