Lecture - 8/23/2011 Combination Products Regulatory...

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8/23/2011 1 Combination Products Regulatory Overview David W. Mullis, Jr., Ph.D., RAC Resource: www.FDA.gov/AboutFDA/CentersOffices/OC /OfficeofScientificandMedicalPrograms/Offic eofCombinationProducts/default.htm PHAR 6010 2 Combination Products Acronyms • OCP – Office of Combination Products • RFD – Request for Designation • QSR – Quality System Regulation • AERS – Adverse Events Reporting System • IND – Investigational New Drug Application • IDE – Investigational Device Exemption • NDA – New Drug Application • PMA – Premarket Approval Application • BLA – Biologics License Application
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8/23/2011 2 3 Definition of Combination Product As defined in 21 CFR § 3.2(e), the term 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. 4 Combination Products • Diverse and Unique Combine Different Types of Products Drug-Device Drug-Biologic Device-Biologic Drug-Device-Biologic
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8/23/2011 3 5 Combination Products •Maybe… Physically or chemically combined Co-packaged in a kit Separate, cross-labeled products 6 Combination Product Examples Examples of combination products where the components are physically, chemically or otherwise combined (21 CFR 3.2(e)(1)): Monoclonal antibody combined with a therapeutic drug Device coated or impregnated with a drug or biologic Drug-eluting stent; pacing lead with steroid-coated tip; catheter with antimicrobial coating; condom with spermicide Skin substitutes with cellular components; orthopedic implant with growth factors Prefilled syringes, insulin injector pens, metered dose inhalers, transdermal patches Examples of combination products where the components are packaged together (21 CFR 3.2(e)(2)):
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Lecture - 8/23/2011 Combination Products Regulatory...

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