FDA Releases New Guidance for Biosimilar Applications
By EsqSocial Corporation 14/05/14
Yesterday, the U.S. Food and Drug Administration provided further clarity as to how it will evaluate applications for approval of biosimilars when it released a draft guidance document outlining the types of clinical pharmacology data it wants to see...
By: Sterne, Kessler, Goldstein & Fox P.L.L.C.