MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....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)

...Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is.....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=80)

Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical...
...Allison recommended that the drug regulations should apply to the drug portions of the product, and the device regulations.....This result highlights the importance of assessing physical stability during drug.....the drug substance was subject to drug GMPs while the drug-device combination product was subject to the quality..
http://www.fda.gov/oc/combination/workshop070803.html (score=80)

Current Good Manufacturing Practice for Combination Products
...Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is.....Under the QS regulation, for a combination product with a drug constituent part, yield and stability requirements would be.....f the PMOA of a device-biological combination product is attributable to the biological product, the Agency component..
http://www.fda.gov/cder/guidance/OCLove1dft.htm (score=80)

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