MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....stem orifice of the valve, the vapor pressure in the container, and the nature of 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)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...This would include any problems associated with the drug product, the valve, the high pressure cylinder, etc.....Drug product containers and closures play a critical role in assuring that the drug product.....problems associated with the valve, the valve seal material, ejection of valve stems, the container..
http://www.fda.gov/cder/dmpq/freshair.htm (score=97)

When Is a Medical Product Too Risky? An Interview with FDA's Top Drug Official
...Why doesn't FDA hold off on approving a drug until the agency is sure the product won't.....Heart valve disease is not known, in general, to be a side effect of pharmaceuticals, and.....People can be seriously harmed by drug-drug interactions, and if they're going to a bunch of..
http://www.fda.gov/fdac/features/1999/599_med.html (score=96)

Guidance for Industry
...ensuring that the drug product provided to the patient has the appropriate identity, strength.....valve assembly, the acceptability of the valve packing and the valve seal used, the type.....if the condition of the drug product, as a result of storage or shipping, casts doubt on the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=96)

Packaging
...It should provide an adequate seal, be compatible with the drug product, and not be a source of.....Complete construction, composition, and description of all component parts of valve closure and container, including valve.....It is also possible for a component of the drug product to migrate through the walls of the..
http://www.fda.gov/cder/guidance/package.htm (score=96)

Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...63 requires that equipment used in the manufacture, processing, packing, or holding of a drug.....The manifolds are equipped with fill connections that correspond only to the container.....Specifications and testing procedures for CMG drug product container/closure systems should..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=93)

FR Notice - Human Cells, Tissues, and Cellular and Tissue-Based Products;...
...Another comment asserted that we should not regulate a product containing a drug or device component unless it.....We do not intend to begin regulating human heart valve allografts and dura mater that meet.....Our ability to regulate an HCT/P as a drug, device, and/or biological product derives from the act and section 351 of the..
http://www.fda.gov/cber/rules/frtisreg011901.htm (score=92)

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based...
...discussion through public meetings, involving an investigational drug or.. Peripheral and.....sterilizing, preserving, or storage agent, product, defined in proposed.. comment.....regulating human heart valve allografts.. recovers or otherwise manufactures. equivalent..
http://www.fda.gov/cber/rules/frtisreg011901.pdf (score=90)

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