PPT-Abatacept (Approved drug)

DB01281 Chemical formula C 3498 H 5458 N 922 O 1090 S 32 Protein average weight 923 kDa with glycosylation Category Antirheumatic Agents and Immunosuppressive Agents . An IRB . Infoshort. August 2013. IND. An Investigational New Drug is a drug that has not yet been approved by the FDA for marketing and is available only for use in research to determine safety and effectiveness.. NEED FOR FURTHER RESEARCH. PATRICIA M KHU, MD,MS. UNIVERSITY OF THE PHILIPPINES MANILA . RESEARCH ETHICS BOARD (UPMREB). CARDINAL SANTOS MEDICAL CENTER . RESEARCH ETHICS REVIEW COMMITTEE (CSMC-RERC). NEED FOR FURTHER RESEARCH. PATRICIA M KHU, MD,MS. UNIVERSITY OF THE PHILIPPINES MANILA . RESEARCH ETHICS BOARD (UPMREB). CARDINAL SANTOS MEDICAL CENTER . RESEARCH ETHICS REVIEW COMMITTEE (CSMC-RERC). FDA and Regulatory Environment As We Enter the User Fee Reauthorization Period. Mike Druckman, Partner, Hogan . Lovells. Mike Druckman. November 2016. FDA Update: Regulatory . Environment . and PDUFA Reauthorization . An IRB . Infoshort. August 2013. IND. An Investigational New Drug is a drug that has not yet been approved by the FDA for marketing and is available only for use in research to determine safety and effectiveness.. Sangeeta Vaswani Chatterjee, . Pharm.D. .. Branch Chief . Supply Chain Response and Enforcement Branch. Division of Supply Chain Integrity. Office of Drug Security, Integrity, and Response. CDER/Office of Compliance. Regulation. Panelists. Isabel . Duffy. . . Associate Vice President. . Merck . & Co., Inc.. Jeff . Handwerker. . Partner. . Arnold . & Porter LLP. Michael . Labson. . . Regulation. Panelists. Isabel . Duffy. . . Associate Vice President. . Merck . & Co., Inc.. Jeff . Handwerker. . Partner. . Arnold . & Porter LLP. Michael . Labson. . . Food and Drug Administration Rockville MD 20857NDA 21-200/S-010 Novartis Pharmaceuticals Corporation Attention Vishwas Ganu PhD Global Regulatory CMC One Health Plaza Please refer to your su For more information wwwfdagov/Know YourSourceUS Food and Drug AdministrationProtecting and Promoting YourKNOW YOUR SOU CE Tchemical entitiessrn KarlsdttirM Sc thesis University of IcelandFacultyof Pharmaceutical SciencesSchool of Health SciencesThe origin of FDA approved natural product new chemical entitiessrn Karlsdtti Susan L. Perlman M.D.. Clinical Professor of Neurology at UCLA. DISCLAIMER. PRESENTER DISCLOSURES. Susan L. Perlman M.D.. The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months:. Infoshort. August 2013. IND. An Investigational New Drug is a drug that has not yet been approved by the FDA for marketing and is available only for use in research to determine safety and effectiveness.. patent brand-name medicines. Low-cost generic drugs—Food and Drug Administration (FDA)-approved, interchangeable versions of the same products made by different manufacturers—were considered