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.....In addition, the molecule could have complex stability and chemistry manufacturing issues.....So, if we think of what do these drug-device combinations do to people, then, everything either..
http://www.fda.gov/oc/combination/transcript112502.html (score=100)

...The effects of the device use on drug stability must be addressed in the device submission, when.....The following represent the general criteria that will apply in making device/drug determinations.....If the labeling of the drug and device create a combination product, as defined in the combination..
http://www.fda.gov/oc/ombudsman/drug-dev.htm (score=97)

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 result highlights the importance of assessing physical stability during drug.....Kruskal described many other possibilities for combined drug/device or biologic/device..
http://www.fda.gov/oc/combination/workshop070803.html (score=83)

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.....12 stability and chemistry manufacturing issues that.. 13 raise safety concerns. 14 If FDA..
http://www.fda.gov/oc/ombudsman/transcript112502.pdf (score=41)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....DPIs, the formulation, and the device with all of its parts including any protective..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=33)

...Any investigational drug, device, or biological product packaged separately that according to.....Under the QS regulation, for a combination product with a drug constituent part, yield and stability requirements would be.....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=85)

Current Good Manufacturing Practice for Combination Products
...Any investigational drug, device, or biological product packaged separately that according to.....Under the QS regulation, for a combination product with a drug constituent part, yield and stability requirements would be.....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=85)

...Nucleic Acid Characterization and Genetic Stability Draft PTC in the Characterization of.....Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain.....Questions and Answers January 1, 1985 Do Do from FDA, from Medical Device and Diagnostic..
http://www.fda.gov/cber/gdlns/guidelst.txt (score=28)

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