MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....reservoir containing sufficient formulation for multiple doses which are metered by the.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

FOOD AND DRUG ADMINISTRATION
...Meyer indicated in his slide, there's a package of information with the formulation/device.....That is expected of the generic or test product going into this issue, that the device be.....So, if a drug is better than placebo, and with all available tests that drug is safe, that drug is safe and..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3763t1.htm (score=78)

...Meyer indicated in his slide, there's a package of information with the formulation/device.....That is expected of the generic or test product going into this issue, that the device be.....So, if a drug is better than placebo, and with all available tests that drug is safe, that drug is safe and..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3763t1.txt (score=78)

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