The Food & Drugs Administration (FDA) is an agency of the United States Department of Health and Human Services (HHS), responsible for protecting the public health through regulation of food, drugs, medical devices, cosmetics, radiation protection materials, tobacco, and certain consumer goods. The FDA regulates foods, dietary supplements, human medicines, veterinary drugs, biological agents, medical devices, and cosmetics under various statutes.
More information about Biologic Product
Products,blood,disease,safety,guidance,patient,application,blood component,conditions,clinical trial,biological product,difference,biologic product,patents.
Food and Drug Administration,molecules,meaningful differences,minor differences,allergenic product,analogous product,amino,report,manufacturing,medical conditions,complex molecule,period,agent,biologic therapies,organic arsenic compound.
Adverse reaction,inactive components,Center for Biologics Evaluation and Research,medical products,product subject,reference product,interchangeable products,health,health care providers,paragraph,manufacturing process,manufacturing practices,Biologics license applications,terms of safety,Federal,route of administration,guidance documents,gene therapies,active ingredient,generic drug,conventional drug.
Biosimilar products,biological drug product,finished product,Health and Human Services,Department of Health,health care professionals,health plan,alpha amino acid polymer,amino acid chains,continued safety,Center for Drug Evaluation and Research, Food and Drug Administration,cure of diseases,chronic condition,molecule drugs,period of time,biological agents,biologic agents,record,psoriatic arthritis,cancers,Puerto Rico,Food and Drugs,business days,European Medicines Agency,scientific literature,Silver Spring,biologic drug,adverse experiences,reference biological,biological product deviations,FDA-approved interchangeable biological products,drug products,Public Health Service,Health Canada,amino acid polymers,amino acids,amino acid chain subunits,requirements in paragraph,infringement under paragraph,applicant under paragraph,adverse experience reports,initial report,eligible patient,notification to patients,application under subsection,blood cells,action for patent infringement,claim of patent infringement,Federal Register,Federal Security Agency,Guidance for Sponsors: Lot Release Program for Schedule D (,debilitating disease,dating period,pharmacy record,patient record,arthritis,Active rheumatoid arthritis,Step therapy,metastatic stomach cancer,American Cancer Society.