FDA Expected To Allow Faster Approval of Some Generics

Law360, New York (October 14, 2003, 12:00 AM EDT) -- In a setback for large pharmaceutical companies, the U.S. Food and Drug Administration is expected to indicate Tuesday that it will allow makers of some generic drugs to use a little-known route to approval that could trim years off their time to reach the market, the Wall Street Journal reported.

The so-called 505(b)(2) process for generic drugs does not require the original proof of safety and effectiveness mandatory for approving new brand-name drugs, nor does it require the same reams of data needed for approving of...
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