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 where both are required to achieve the intended use.....4) Any investigational drug, device, or biological product packaged separately that according to..
http://www.fda.gov/oc/combination/definition.html (score=100)

FIRST DRUG DEVICE COMBINED TREATMENT FOR CERTAIN PRE-CANCEROUS SKIN...
...It is the first combined drug and device treatment designed for targeted treatment that can be.....P99-31 FOOD AND DRUG ADMINISTRATION FOR IMMEDIATE RELEASE Print Media: 301-827-6242.....FIRST DRUG DEVICE COMBINED TREATMENT FOR CERTAIN PRE-CANCEROUS SKIN LESIONS APPROVED.. The Food..
http://www.fda.gov/bbs/topics/NEWS/NEW00704.html (score=77)

MedWatch Home Page
...MedWatch Home Page..
http://www.fda.gov/medwatch/index.html (score=46)

Assignment of Combination Products/Product Jurisdiction Program
...Such decisions may involve determinations of the regulatory identity of a product as a drug.....drug, device, or biological product where such jurisdiction is unclear or in dispute. By.....drug, device, or biological product where such jurisdiction is unclear or in dispute. The..
http://www.fda.gov/oc/combination/assignment.html (score=41)

file:///C|/Daily/1125fda.txt
...12 the drug or the device, so again, the typical NDA, 13 aNDA process for the drug or the contrast.....23 drug or the device, or perhaps to both components, 24 and the labeling may not be the same between.....4 components specific issues, for example, 5 effectiveness between the drug and the device..
http://www.fda.gov/oc/ombudsman/transcript112502.pdf (score=37)

FR Doc 03-15698
...Background A combination product is a product containing a combination of a drug, a device, or a.....FDA is taking this action to implement the requirement of the Medical Device User Fee and.....1) The regulatory identity of a product as a drug, device, biologic, or combination..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-15698.html (score=37)

Microsoft Word - SOP Ver 4 _Fax Number Changes_ 6-18-04.doc
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically.....drug, device, or biological product where both are required to achieve the intended use.....4) Any investigational drug, device, or biological product packaged separately that according to..
http://www.fda.gov/oc/ombudsman/intercentersop.pdf (score=32)

...Any investigational drug, device, or biological product packaged separately that according to.....Background Section 501 of the Act states the circumstances under which a drug or device is deemed.....For example, for a drug-coated device, the drug constituent part would be subject only to the CGMP..
http://www.fda.gov/cder/guidance/OCLove1dft.doc (score=32)

...the agency anticipates that the Drug/Device Intercenter Agreement will be amended to reflect.....drug/device products and to combination biologic/device products that currently are regulated.....drug/device and biologic/device combinations) that contain natural rubber device components to..
http://www.fda.gov/cber/genadmin/rubber.txt (score=28)

Current Good Manufacturing Practice for Combination Products
...Any investigational drug, device, or biological product packaged separately that according to.....Section 501 of the Act states the circumstances under which a drug or device is deemed adulterated.....For example, for a drug-coated device, the drug constituent part would be subject only to the CGMP..
http://www.fda.gov/cder/guidance/OCLove1dft.htm (score=28)

CDRH Ombudsman - Resources
...drug, device, and biological products when the jurisdiction over a product is unclear or..
http://www.fda.gov/cdrh/ombudsman/resources.html (score=28)

Development of Drugs, Devices, and Drug-Device Combinations: FDA for...
...19-Apr-04..
http://www.fda.gov/ohrms/dockets/ac/04/questions/4033q1_02_FDA%20Panel%20Question%20slides.htm (score=28)

Definition of Primary Mode of Action of a Combination Product
...360c­360f, 360h­360j, 360gg­360ss, product has a device mode of action, the present.....device, or drug mode of action, important therapeutic action of the .. combination products will.....designed for controlled drug release, effectiveness questions with regard to .. will make..
http://www.fda.gov/cber/rules/comboprod.pdf (score=24)

FY05 OCP Review Performance: Formal Requests for Designation Submitted by...
...4 device/biologic.. 3 total: 2 drug/device.. 1 device/biologic.. 3 total: 3 drug/device..
http://www.fda.gov/oc/combination/fy05rfd.html (score=24)

FDA PROPOSES FINANCIAL DISCLOSURE FOR CLINICAL INVESTIGATORS
...The proposal would require the sponsor of any drug, biological product or device marketing application to provide FDA.....drug, device or biological product approval applications. The following can be used to..
http://www.fda.gov/bbs/topics/ANSWERS/ANS00603.html (score=24)

Assignment of Agency Component for Review of Premarket Applications
...Background A combination product is a product containing a combination of a drug, a device, or a.....FDA is taking this action to implement the requirement of the Medical Device User Fee and.....1) The regulatory identity of a product as a drug, device, biologic, or combination..
http://www.fda.gov/cber/rules/premktapp.htm (score=24)

Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical...
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise.....the drug substance was subject to drug GMPs while the drug-device combination product was subject to the quality.....Kruskal described many other possibilities for combined drug/device or biologic/device..
http://www.fda.gov/oc/combination/workshop070803.html (score=24)

Overview of the Office of Combination Products
...The law gives the Office broad responsibilities covering the regulatory life cycle of drug.....For example, innovative drug delivery devices have the potential to make treatments safer.....drug-device, drug-biologic, and device-biologic products) are increasingly incorporating..
http://www.fda.gov/oc/combination/overview.html (score=24)

Transcript of the Public Hearing on November 25, 2002 on FDA Regulation of...
...The drug alone has issues, but the drug-device combination also has issues, and these must not be underestimated because of.....So, if we think of what do these drug-device combinations do to people, then, everything either.....Angiogene develops unique drug-device combination products that increase the success rate of..
http://www.fda.gov/oc/combination/transcript112502.html (score=19)

Theresa A. Toigo as the Acting Director of FDA's Office of Women’s...
...Food and Drug Administration Commissioner Lester M. Crawford announces the appointment of.....drug, device and biologics testing, and regulation policy; Monitors progress of priority women's.....Food and Drug Administration Commissioner Lester M. Crawford today announced the..
http://www.fda.gov/bbs/topics/news/2005/toigoOWH.html (score=19)

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