FDA Revises Generic-Drug Application Policy

Law360, New York (October 18, 2006, 12:00 AM EDT) -- The U.S. Food and Drug Administration has updated the way it reviews new generic drug applications, which should shorten the time it takes to complete some of those reviews.

Since 1990, the FDA’s Office of Generic Drugs has always appraised submissions on a “first-in, first-reviewed” basis. Starting Wednesday, however, the agency said applications would be expedited for first generic drugs with no blocking patent.

“Ensuring that at least one generic medicine will be available to consumers when a brand’s patent expires is good news for consumers,”...
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