1. A product consisting of multiple parts or elements. 2. A combination of items assembled into a whole; especially : a set (as of dishes) or a collection (of books). 3. An item or element that serves as an integral part of something else. 4. A group of things that work together. 5. A thing made up of parts or elements. 6. Something that is put together out of parts or elements. 7. A number of people who share common interests or goals. 8. A person who shares
More information about Combination Product
Drug application,compliance,single entity,medical products,process,Food and Drug Administration,Primary mode,review of combination products,separate products,premarket approval application,issues,health,public health,authority.
Investigational plan,single package,drug constituent,medical devices,primary jurisdiction,biological product constituent part,requirements for combination product,device products,drug products,Co-packaged combination product,investigational combination products,Single-entity combination product,therapeutic action.
Mode of action,safety reporting requirements,review process,classification request,route of administration,chapter,event,dosage form,investigational drug,single mode,device constituent,Combination product applicant,combination product regulation,Biological product deviation reports,recordkeeping requirements,regulatory requirements,Agency component,device application,application type,abbreviated application,biologics license application,safety information request,compliance with paragraph,chapter with respect,chapter for corrections,guidance document,draft guidance,study,Premarket notification submission,safety events,management,search,calendar days,(ii) Fifteen-day reports,(i) Five-day reports,Malfunction report,report interval,surgical instruments,periodic safety reports,followup reports,type of report,effective premarket review,applicable regulations,manufacturing practice regulations,regulation applicable,constituent part applicants,reporting requirements applicable,biological product mode,allergenic product,analogous product,product applicable,combination product types,regulation of combination products,single-entity or co-packaged combination product,assignments of combination products,biologic-led combination products,drug-led combination product,medical product center,“Cross-labeled” combination products,modes of action,purposes through chemical action,mode of action expected,mode of action will,manufacturing practice requirements,tissue practice requirements,applicable manufacturing requirements,agency centers,agency intent,development process,request for designation,compliance with respect,definition of device contained,definition of drug contained,adverse events,therapeutic effects,drug CGMPs,Federal Register,manufacturing practice operating system,requests for designation,therapeutic serum,Eli Lilly and Company,timeliness of premarket review,types of mode,antimicrobial swabs,drug mode,device mode,identifiable mode,annual reports,device component,postmarket regulation,component responsible,assignment of combination products,hydrocodone combination product,assignment of products,Borderline products,medicinal products,applications for combination products,product sponsor,product jurisdiction officer,mode of action provides,drug action,mode of action would,statutory requirement,agency reviewers,agency for review,agency practice,assignment process,designation process,U.S. Food and Drug Administration,administration,effectiveness issues,major issues,Advisory issues,compliance costs,study sponsor,observational studies,paper submission,National Institutes of Health,competent authority,authority citation,Lean Management,Lean Management Staff,search feature,Advanced Search.