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=100)

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=82)

Future Trends in Medical Device Technology:
...During the Fall of 1997, the Food and Drug Administration's (FDA) Center for Devices and.....device technologies over the next ten years. This study was performed in support of CDRH's.....device/drug hybrid products, and (6) organ replacement/assist devices employing both hardware and..
http://www.fda.gov/cdrh/ost/trends/toc.html (score=82)

Document
...Food and Drug Administration, our laboratory preparedness. HHS. intends to make the 2004.....academic and clinical communities, limited to device, drug, and biological.....device or biologic and device products .. evolving technology? registration deadline is..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14212.pdf (score=45)

...The changes to the medical device and expansion programs are effective January 1, 2001.....device, drug, food, and biologics inspections based on the outcome of the expansion of the medical.....The Food and Drug Administration (FDA) is announcing some changes in its standard..
http://www.fda.gov/OHRMS/DOCKETS/98fr/010401c.htm (score=45)

Part 2, medical devices and radiological health, FY 2003 Annual Performance Plan
...Some device-specific review time definitions follow to help stakeholders interpret device.....For 510(k)s, section 510(k) of the Federal Food, Drug and Cosmetic Act establishes a 90.....For the Device and Radiological Health program, Counter-terrorism activities include..
http://www.fda.gov/ope/fy03plan/part2_med.html (score=44)

Part 2, medical devices and radiological health, FY 2003 Annual Performance Plan
...Some device-specific review time definitions follow to help stakeholders interpret device.....For 510(k)s, section 510(k) of the Federal Food, Drug and Cosmetic Act establishes a 90.....For the Device and Radiological Health program, Counter-terrorism activities include..
http://www.fda.gov/ope/FY03plan/part2_med.html (score=44)

FR Doc 05-18871
...David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900.....1) FDA regulation of the conduct of clinical research; (2) medical device, drug, and.....Drug Administration Industry Exchange Workshop on Food and Drug Administration Clinical..
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-18871.htm (score=44)

FR Doc 05-5978
...A drug, device, or biological product packaged separately that according to its investigational.....How important is it that drug and device labeling be consistent with respect to intended use, dose.....The two products that will be used together could be a drug and a device, a drug and a biological product, or a..
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-5978.htm (score=44)

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=26)

FDA/DHHS: FDA and the Internet, Advertising and Promotion of Medical...
...There are, of course, in the device industry, as there are in the drug industry, a lot of very good, very ethical companies.....You may be trying to get a drug better than the drug out on the market, and hopefully you are trying to get a.....To put the question into a device context, certainly, if the device is investigational, the advertising that would be..
http://www.fda.gov/opacom/morechoices/transcript1096/fdainet2.html (score=26)

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=26)

ANNUAL REPORT TO CONGRESS
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise.....Ten of the products were determined to be drug-device combinations, one is a device-biologic.....This includes requests for classification of a product as a biological product, device or drug, as..
http://www.fda.gov/oc/combination/congressreport.html (score=25)

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=25)

IDE POLICIES AND PROCEDURES
...This guidance defines an unapproved medical device as a device that is utilized for a purpose.....device, drug, or other therapy exists. Under the final rule, treatment use of an investigational.....Drug Administration (FDA) encourages sponsors to begin communicating with the ODE..
http://www.fda.gov/cdrh/ode/idepolcy.html (score=25)

510(k)s Final Decisions Rendered
...SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST DRUG DETECTION DEVICES, LTD. 510(k.....01-DEC-99 HILLSBOROUGH CAMPUS 510(k) SUMMARY AVAILABLE FROM FDA SOMERVILLE, NJ 08876.....06-DEC-99 HERMINKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA TAMPERE, FINLAND FIN-33720..
http://www.fda.gov/cdrh/510k/sumdec99.html (score=25)

CBER - Tissue Action Plan - Reinventing the Regulation of Human Tissue
...The Food and Drug Administration's sixth "Reinventing Government" report, produced in.....device, drug, or biologic). Metabolic products raise potentially serious systemic safety.....These products would have to receive an Investigational New Drug (IND) exemption or Investigational Device Exemption (IDE) prior..
http://www.fda.gov/cber/tissue/rego.htm (score=25)

FR Doc 05-16527
...A drug-device combination product with a device PMOA, where the device is regulated by CBER.....The comment also provided alternative definitions for device MOA, drug MOA, and biological product MOA.....We have also addressed our rationale for the development of the definitions of device MOA, drug MOA..
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-16527.htm (score=25)

Resolution of Disputes Concerning Fees Under MDUFMA
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically.....individually specified drug, device, or biological product where both are required to.....comprised of drug and device products, device and biological products, or biological and..
http://www.fda.gov/cdrh/mdufma/guidance/1303.pdf (score=25)

G:\RES\EADOCS\PDFFIL~1\COPIES~1\OC03366.XML
...drug/device, biological product/device, drug/ biological product, or drug/device/biological product, that are physically, chemically.....are comprised of more than one type of regulated article (biological product, device, or.....device action, to correct vision. Another action of the product is a drug action, to treat..
http://www.fda.gov/OHRMS/DOCKETS/98fr/oc03366.pdf (score=25)

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