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Article: FDA announces measures to improve generic drug access.
- Article from:
- M2 Presswire
- Article date:
- March 2, 2004
CopyrightCOPYRIGHT 2004 Normans Media Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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M2 PRESSWIRE-2 March 2004-US FDA: FDA announces measures to improve generic drug access(C)1994-2004 M2 COMMUNICATIONS LTD
RDATE:03022004
The Food and Drug Administration (FDA) today announced that it will provide more information to the public to help generic drug applicants determine if they are eligible for 180-day marketing exclusivity for their products. This period of marketing exclusivity is generally provided to the first generic drug that challenges a patent for the innovator product. This marketing exclusivity is an effective incentive for generic drug development provided under the Hatch-Waxman Amendments to the Federal Food Drug and Cosmetic ...