chemical distinction / similar already-approved products / that no products / biological products / biotechnology / biotechnology-derived biologic product basedon agency findings / follow-on biologic products / drug substanceand product / drug product / biotechnology products / samedrug product / generic product / becauseall biological products / abbreviated new drug applications / biologic product / allergenic product / biological product / follow-on manufacturer / Synthetic small-molecule drug products / biological drug products / manufacturing requirements / listed innovator product / marketed drug products / manufacturing processto assuring / follow-on biologic product / pharmaceutical technology / demonstratedwith current technology / chemical structures / generic manufacturer / manufacturing process / pharmaceutical equivalence / follow-on product / unrelated manufacturers / analogous product / synthesizeddrug products / live cellular products / biologic products / manufacturing / drug products / scientific technology / becauseeach biologic product / /
MedicalTreatment
drug therapy / /
Organization
Center for Drugs and Biologics / HAND DELIVERY Division / SenateJudiciary Committee / Congress / Center for Biologics Evaluation / Division of Dockets Management / U.S. Food and Drug Administration / US Federal Reserve / Center for Drug Evaluation / PHSA / /
Person
H. Meyer / Lester M. Crawford / Mark B. McClellan / / /
VIA HAND DELIVERY Division of Dockets Management U.S. Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD[removed]Re: