Generic Line
May 5, 2004
| Vol.
21 No.
9
HATCH-WAXMAN GENERIC REFORMS BECOMING EVIDENT, OTHER UNKNOWNS LOOM
While the effects of last year’s drug patent reforms are still sinking in, one change has become clear: The agency has not received a single polymorph patent for filing in the FDA’s Orange Book since the new rules kicked in last August, according to agency officials.
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