Exploring emerging nanobiotechnology drugs and medical devices

Food and Drug Law Journal

Volumn 63, Issue 2, 2008, Pages 407-420

  Paradise, Jordan ^a   Diliberto, Gail Mattey ^a   Tisdale, Alison W ^b   Kokkoli, Efrosini ^b  

^a UNIVERSITY OF MINNESOTA LAW SCHOOL   (United States)

^b UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; ANTINEOPLASTIC AGENT; BIOMATERIAL; CYTARABINE; DOXORUBICIN; ESTASORB; ESTRADIOL; ESTROGEN; HEPATITIS A VACCINE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LIPOSOME; MACROGOL; NANOPARTICLE; PACLITAXEL; PEPTIDE; POLYMER; RAPAMYCIN; VITOSS;

BONE GRAFT; BONE PROSTHESIS; BONE REMODELING; BREAST CANCER; CATHETER; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CONTROLLED DRUG RELEASE; DENTAL BONDING; DIAGNOSTIC KIT; DRUG DELIVERY SYSTEM; DRUG ELUTING STENT; DRUG FORMULATION; DRUG LEGISLATION; ENCAPSULATION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEPATITIS A; HOT FLUSH; HUMAN; IMMUNOASSAY; KAPOSI SARCOMA; KIDNEY GRAFT REJECTION; MEDICOLEGAL ASPECT; MENINGITIS; MULTIPLE MYELOMA; NANOBIOTECHNOLOGY; NANODEVICE; NANOMEDICINE; OPTICAL COHERENCE TOMOGRAPHY; OVARY CANCER; PATIENT SAFETY; REVIEW; STANDARDIZATION; SURGICAL INSTRUMENT; TABLET FORMULATION; TISSUE ENGINEERING; TISSUE REPAIR; WOUND DRESSING;

BIOTECHNOLOGY; DEVICE APPROVAL; DIAGNOSTIC TECHNIQUES AND PROCEDURES; DRUG APPROVAL; DRUG DELIVERY SYSTEMS; FORECASTING; HUMANS; NANOMEDICINE; NANOSTRUCTURES; NANOTECHNOLOGY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 44849094646     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

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94. "Combination product includes: 1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; 2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; 3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or 4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect." Federal Food, Drug, and Cosmetic Act, 21 CFR 3.2(e).
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