FDA Releases Guidelines for 12-Year Period of Reference Product Exclusivity for Section 351(a) Biologics

Published date15 August 2014
Law FirmSterne, Kessler, Goldstein & Fox P.L.L.C.
AuthorTimothy J. Shea
Subject MatterBiologics,Biosimilars,Exclusive Use,FDA,Guidance Update,Product Exclusivity

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