Definition of a Combination Product
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise.....drug, device, or biological product packaged separately that according to its investigational plan or proposed.....drug, device, or biological product where both are required to achieve the intended use, indication, or effect and..
http://www.fda.gov/oc/combination/definition.html (score=100)

FR Doc 05-5978
...Company B develops a device to deliver Company A's approved drug product for a different indication, to be delivered by a different.....A drug, device, or biological product packaged separately that according to its investigational plan or proposed.....The two products that will be used together could be a drug and a device, a drug and a biological product, or a biological product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-5978.htm (score=55)

Document
...Food and Drug Administration, our laboratory preparedness. HHS. intends to make the 2004.....academic and clinical communities, limited to device, drug, and biological.....public expected to use the product, patients. To test a methodology for .. July 31, 2003..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14212.pdf (score=55)

MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....DPIs, the formulation, and the device with all of its parts including any protective.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=34)

...Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is.....Background Section 501 of the Act states the circumstances under which a drug or device is deemed.....Examples include aseptic control assurance for drug and biological product constituent parts unable to..
http://www.fda.gov/cder/guidance/OCLove1dft.doc (score=32)

Current Good Manufacturing Practice for Combination Products
...Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is.....Section 501 of the Act states the circumstances under which a drug or device is deemed adulterated.....Examples include aseptic control assurance for drug and biological product constituent parts unable to..
http://www.fda.gov/cder/guidance/OCLove1dft.htm (score=32)

FDA Radiological Emergency Response Plan Summary
...stockpile issues, including labeling, appropriate usage, product performance, monitoring.....jurisdiction for review of combination products (drug-device, drug-biologic, and device.....investigation that a firm in another district is responsible for the product involved in..
http://www.fda.gov/oc/ocm/radplan.pdf (score=32)

FDA Chemical and Biological Emergency Response Plan
...Providing regulatory guidance on the use of medical countermeasures when either the drug.....Providing advice in the assessment of animal drug or feed product involving a biologic or chemical.....drug-device, drug-biologic, and device-biologic products). OCP works with FDA Centers to..
http://www.fda.gov/oc/ocm/cbplan.html (score=32)

...If the labeling of the drug and device create a combination product, as defined in the combination product regulations, then.....Drug incorporating a device component with the combination product having the primary intended purpose of.....Device incorporating a drug component with the combination product having the primary intended purpose of..
http://www.fda.gov/oc/ombudsman/drug-dev.htm (score=32)

ANNUAL REPORT TO CONGRESS
...This includes requests for classification of a product as a biological product, device or drug, as well as requests for lead Center.....drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise.....Product specific issues involved a diverse array of combination products in product areas..
http://www.fda.gov/oc/combination/congressreport.html (score=32)

Office of Combination Products Report to Congress
...drug, device, or biological product where both are required to achieve the intended use.....drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically.....product as a biological product, device or drug, as well as requests for lead Center..
http://www.fda.gov/oc/combination/Congressreport.pdf (score=32)

FR Doc 05-16527
...A drug-device combination product with a device PMOA, where the device is regulated by CBER, would be assigned to.....We have also addressed our rationale for the development of the definitions of device MOA, drug MOA, and biological product MOA.....The comment also provided alternative definitions for device MOA, drug MOA, and biological product MOA..
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-16527.htm (score=31)

Guidance for Industry and FDA - Current Good Manufacturing Practice for...
...Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is.....Section 501 of the Act states the circumstances under which a drug or device is deemed adulterated.....Examples include aseptic control assurance for drug and biological product constituent parts unable to..
http://www.fda.gov/oc/combination/OCLove1dft.html (score=31)

Guidance for Industry and FDA Staff: Application User Fees for Combination...
...For example, a biologic-device or a drug-device combination product for which a PMA is required should be subject to the PMA.....Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is.....drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise..
http://www.fda.gov/oc/combination/userfees.html (score=31)

DRUG INFORMATION ASSOCIATION
...Another example is when a drug product is approved with a specialty delivery device and they.....You are not always going to be aware of whether there is a drug-device or a drug-biologic or a.....For the drug product, again, if you have an approved NDA or IND for that drug product, then..
http://www.fda.gov/oc/combination/presentations/dia/transcript.html (score=31)

U.S. Food and Drug Administration Radiological Emergency Response Plan
...Providing regulatory guidance on the use of medical countermeasures when either the drug.....A device designed to spread radioactive material by conventional explosives when the bomb.....Providing advice in the assessment of animal drug or feed product involving radiological..
http://www.fda.gov/oc/ocm/radplan.html (score=31)

Guidance for Industry and FDA Staff: Application User Fees for Combination...
...For example, a biologic-device or a drug-device combination product for which a PMA is required will be subject to the PMA fee.....Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is.....drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise..
http://www.fda.gov/oc/combination/cleanuser.html (score=31)

Guidance for Industry and FDA Current Good Manufacturing Practice for...
...12 Each set of regulations also allows either a device or a drug manufacturer who is engaging in only.....ensure the product possesses adequate strength, quality, identity, and purity of a drug or.....the device, and a drug manufacturer only has to comply with the regulations in 21 CFR 210..
http://www.fda.gov/cber/gdlns/gmpcombo.pdf (score=31)

FDA Nanotechnology | FAQ's
...a product comprised of both a drug and a device, a device and a biological product, or a drug and a biological.....For example, if the PMOA of a device-biological combination product is attributable to the biological product, the.....For example, environmental considerations relating to drug approvals can include toxicity..
http://www.fda.gov/nanotechnology/faqs.html (score=31)

Frequently Asked Questions for Office of Combination Products
...A drug, device, or biological product packaged separately that according to its investigational plan or proposed.....Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is.....new drug product exclusivity, orphan status, or proprietary data protection when two firms are..
http://www.fda.gov/oc/combination/faqs.html (score=31)

Las Vegas Injury Lawyer