MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....DPIs, the formulation, and the device with all of its parts including any protective.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

PMA Final Decisions Rendered for December 1995
...APPROVAL OF MINIMUM 12/13/95 DEVICE DOSE GAMMA CONFIGURATION OF WARSAW, IN IRRADIATION THE NEW.....DRUG SUBSTANCE P880087/S006 ANTERIOR CHAMBER ALCON LABORATORIES APPROVAL FOR AN 12/13/95.....APPROVAL OF MINIMUM 12/13/95 TOTAL KNEE SYSTEM DOSE GAMMA WARSAW, IN IRRADIATION 46581..
http://www.fda.gov/cdrh/pmadec95.html (score=36)

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