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.....5 believes that separate filings may be appropriate, 6 but the key to this recommendation.....23 drug or the device, or perhaps to both components, 24 and the labeling may not be the same between..
http://www.fda.gov/oc/ombudsman/transcript112502.pdf (score=100)

...Any investigational drug, device, or biological product packaged separately that according to.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....Background Section 501 of the Act states the circumstances under which a drug or device is deemed..
http://www.fda.gov/cder/guidance/OCLove1dft.doc (score=88)

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.....review will be used to assist the requesting reviewer in making appropriate regulatory.....drug, device, or biological product where both are required to achieve the intended use..
http://www.fda.gov/oc/ombudsman/intercentersop.pdf (score=88)

Current Good Manufacturing Practice for Combination Products
...Any investigational drug, device, or biological product packaged separately that according to.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....Section 501 of the Act states the circumstances under which a drug or device is deemed adulterated..
http://www.fda.gov/cder/guidance/OCLove1dft.htm (score=80)

CDRH Ombudsman - Resources
...Because the FDA Office of the Ombudsman has agency-wide jurisdiction, it is appropriate to.....drug, device, and biological products when the jurisdiction over a product is unclear or.....The FDA Office of the Ombudsman also determines the appropriate classification and..
http://www.fda.gov/cdrh/ombudsman/resources.html (score=80)

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.....This was a very appropriate topic, since new device technologies often permit more.....Device-drug combinations that incorporated drugs that are new, have a different indication, a..
http://www.fda.gov/oc/combination/workshop070803.html (score=73)

Transcript of the Public Hearing on November 25, 2002 on FDA Regulation of...
...In certain cases, as recognized earlier by some of the previous speakers, where the drug and device interact together, it may be.....We believe that applications both by the drug manufacturer and by the device manufacturer are appropriate in this case.....The drug alone has issues, but the drug-device combination also has issues, and these must not be underestimated because of..
http://www.fda.gov/oc/combination/transcript112502.html (score=69)

FR 9/30/97 Natural Rubber-Containing Medical Devices; User Labeling
...At this time, the agency anticipates that the Drug/Device Intercenter Agreement will be amended.....While this test may be appropriate for detecting sensitization to residual levels of.....The agency, for example, has applied both drug and device authorities, and both biological and..
http://www.fda.gov/cdrh/dsma/fr93097.html (score=56)

Office of Combination Products Report to Congress
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically.....products, and the consistent and appropriate postmarket regulation of these products to.....that cover the entire regulatory life cycle of drug-device, drug-biologic, device-biologic, and drug-device-biologic combination..
http://www.fda.gov/oc/combination/Congressreport.pdf (score=56)

ANNUAL REPORT TO CONGRESS
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise.....One of these working groups established a process to ensure appropriate communication and.....Ten of the products were determined to be drug-device combinations, one is a device-biologic..
http://www.fda.gov/oc/combination/congressreport.html (score=56)

...Sponsors may meet with representatives from the appropriate new drug review division and the Office of.....12] Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on..
http://www.fda.gov/cder/guidance/5767dft.doc (score=48)

Microsoft Word - 5767dft.doc
...12 Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the.....representatives from the appropriate new drug review division and the Office of Drug.....15 Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the..
http://www.fda.gov/cder/guidance/5767dft.pdf (score=48)

Draft Guidance for Industry: Good Pharmacovigilance Practices and...
...12 Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the.....representatives from the appropriate new drug review division and the Office of Drug.....15 Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the..
http://www.fda.gov/cber/gdlns/pharmacovig.pdf (score=48)

...Sponsors may meet with representatives from the appropriate new drug review division and the Office of.....12] Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0189-gdl0001-5767dft.doc (score=48)

Draft Guidance for Industry: Good Pharmacovigilance Practices and...
...Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the United.....Sponsors may meet with representatives from the appropriate new drug review division and.....Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the United..
http://www.fda.gov/cber/gdlns/pharmacovig.htm (score=48)

Combination Products Timeliness of Premarket Reviews Dispute Resolution...
...For example, if a combination product consisting of drug and device constituent parts is to be.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....For example, if a combination product consisting of drug and device constituent parts is to be..
http://www.fda.gov/oc/combination/dispute.html (score=48)

Microsoft Word - Guidance Final April 16 2004.doc
...For issues arising within the Center for Drug Evaluation and Research, contact: Warren.....would be appropriate to direct the timeliness dispute to OCP. OCP encourages timeliness.....drug and device constituent parts is to be reviewed under both a device ..application and a new..
http://www.fda.gov/oc/combination/dispute.pdf (score=48)

/a/content.20322
...New combination products, such as food-drug and drug-device combinations, will continue to.....reviews and inspections are appropriate and what other work needs to be accom-plished to.....quency for the inspection of any food establishment, or those drug, biologic and device..
http://www.fda.gov/oc/fdama/fdamapln/fdamapln.pdf (score=44)

...New combination products, such as food-drug and drug-device combinations, will continue to be generated.....to the appropriate parties, and that might be professional societies, physicians, medical.....This framework, outlined in Section 903 of the Federal Food, Drug, and Cosmetic Act as..
http://www.fda.gov/cber/genadmin/statcomp.txt (score=44)

...For example, a drug-coated device may be subject to the device Quality Systems Regulation for the.....In addition, where the agency finds it is appropriate, the agency reserves the option to.....device postmarketing reporting for the combination product, with drug current good..
http://www.fda.gov/OHRMS/DOCKETS/98fr/102802b.htm (score=44)

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