title: Regulatory aspects of new medicines targeted at treatment of autoimmune diseases.
abstract: Autoimmune diseases comprise a diverse group of clinical dis orders that result from the body's adaptive immune system reacting against its own tissues.(1) Conversely, autoinflammatory disorders encompass a more limited group of diseases distinguished by recurrent episodes of inflammation but in the absence of high-titer autoantibodies and antigen-specific T cells.(2) The past 15 years have seen a tremendous growth in the development of highly effective treatments for these diseases.
authors.affiliation: Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. keith.hull@fda.hhs.gov
authors.forename: K M
authors.initials: KM
authors.lastname: Hull
authors.forename: S
authors.initials: S
authors.lastname: Yim
mesh_terms: D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000627:therapeutic use; D001323:Autoantibodies / Q000627:therapeutic use; D001327:Autoimmune Diseases / Q000276:immunology* / Q000378:metabolism* / Q000628:therapy*; D001688:Biological Products / Q000008:administration & dosage*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016503:Drug Delivery Systems / Q000379:methods*; D006801:Humans
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001323:Autoantibodies; D001688:Biological Products