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Get S D Rulesandregulators - Pubs Acs

R entry into the generic market and to the protections provided to patents of the innovator companies were put forth to restore and enhance balance to the playing field of the pharmaceutical marketplace (1, 2). The new rules come in response to what many consider loopholes in the original 1984 Hatch Waxman legislation for abbreviated generic drug approval. The reforms, labeled the Final Rule by the FDA, have two central accomplishments. The first is the elimination of the possibility of obtain.

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