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=100)

Sterilized Convenience Kits for Clinical and Surgical Use; Final Guidance...
...For example, the package integrity of all device components should remain in tact for any.....For questions regarding prescription drug products, call the Division of Prescription Drug.....stability data. The expiration dates for device components should be revised based on data..
http://www.fda.gov/cdrh/comp/guidance/1390.html (score=230)

file:///C|/Daily/1125fda.txt
...23 drug or the device, or perhaps to both components, 24 and the labeling may not be the same between.....12 the drug or the device, so again, the typical NDA, 13 aNDA process for the drug or the contrast.....4 components specific issues, for example, 5 effectiveness between the drug and the device..
http://www.fda.gov/oc/ombudsman/transcript112502.pdf (score=76)

Transcript of the Public Hearing on November 25, 2002 on FDA Regulation of...
...We all recognize that the combination of two components, such as a drug and a device, bring new development issues, such as.....In addition, the molecule could have complex stability and chemistry manufacturing issues.....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=76)

ODE Guidance Documents
...Drug/Biologic Stability If the device labeling indicates that the drug or biologic is to be stored in the syringe.....All purchased drug or biologic components are also packaged and labeled consistent with their approval or.....Drug/Biologic and Device Compatibility Data demonstrating drug or biologic and material compatibility is..
http://www.fda.gov/cdrh/ode/odegr821.html (score=58)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...conditions and verification of its stability under the conditions described should be.....address during the investigation of a new animal drug and preparation of an.....Your application should include a stability protocol containing, but not limited to..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=45)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...conditions and verification of its stability under the conditions described should be.....address during the investigation of a new animal drug and preparation of an.....Your application should include a stability protocol containing, but not limited to..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=45)

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.....AdvaMed noted that in combination products that have separate components, historically the..
http://www.fda.gov/oc/combination/workshop070803.html (score=43)

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