MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....DPIs, the formulation, and the device with all of its parts including any protective.....recommended for inclusion in the application regarding the components, manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...including the data from the material used to prepare clinical/pre-clinical lots and.....address during the investigation of a new animal drug and preparation of an.....include the protocol to be used, number of final lots/serials to be entered into the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf (score=76)

Draft Guidance for Industry: Drugs, Biologics and Medical Devices Derived...
...including the data from the material used to prepare clinical/pre-clinical lots and.....address during the investigation of a new animal drug and preparation of an.....include the protocol to be used, number of final lots/serials to be entered into the..
http://www.fda.gov/cber/gdlns/bioplant.pdf (score=76)

FR 9/30/97 Natural Rubber-Containing Medical Devices; User Labeling
...Combination products that have device and drug components but are regulated under drug premarket approval.....Device container vials with dry natural rubber stoppers, when used in combination with a.....The agency intends to require that all combination products that contain natural rubber device..
http://www.fda.gov/cdrh/dsma/fr93097.html (score=12)

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