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=85)

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=69)

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=67)

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=64)

Human Drug Notes
...Any residues must not adversely alter drug product safety, efficacy, quality, or stability.....valve and external examination, labeling, coloring, correct valve, etc. Finally, the firm.....The CGMP regulations promulgated under the Food, Drug, and Cosmetic Act 5 HUMAN DRUG CGMP NOTES June, 1995 and codified..
http://www.fda.gov/cder/hdn/hdn695.htm (score=56)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The specific valve used in each MDI drug product should be carefully selected considering the type and critical.....To qualify for these statutory exemptions, a compounded drug product must satisfy several.....Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect on the..
http://www.fda.gov/cder/fdama/difconc.htm (score=44)

GUIDE TO INSPECTIONS OF
...If on the next day or start-up of the operation the primary valve off of the circulating.....For example, purified water used to manufacture drug products by cold processing should be.....One of the basic considerations in the design of a system is the type of product that is..
http://www.fda.gov/ora/inspect_ref/igs/high.html (score=42)

GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS
...In an inspection of a biopharmaceutical drug product, a Pseudomonas problem probably attributed.....When this valve is closed the chamber is isolated from the external condenser. Also known.....The free water in a product is that water that is absorbed on the surfaces of the product..
http://www.fda.gov/ora/inspect_ref/igs/lyophi.html (score=33)

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=32)

GUIDE TO INSPECTIONS ORAL SOLUTIONS AND SUSPENSIONS , FDA, ORA
...The design of the batching tank with regard to the location of the bottom discharge valve.....Observe the addition of drug substance and powdered excipients to manufacturing vessels to.....From a potency aspect, the storage of product at high temperatures may increase the level..
http://www.fda.gov/ora/inspect_ref/igs/oral.html (score=32)

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=31)

...This document is not intended to spell out how to conduct a CGMP drug inspection or set.....If the change gives increased assurance of product quality, then the change can be put.....b) Microprocessors can be used for controlling a steam valve, maintaining pH, etc. They..
http://www.fda.gov/ora/inspect_ref/igs/csd.html (score=31)

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=30)

Jurisdictional Update: Metered Dose Inhalers, Spacers and Other Accessories
...Based on FDA’s determination that the primary mode of action of the combination product is attributable to its drug.....valve utilized in the product. For dose counters to provide accurate information, the.....Based on FDA’s determination that the primary mode of action of the combination product is attributable to its drug..
http://www.fda.gov/oc/combination/mdiupdate.html (score=30)

10056733r03
...Clinically significant pharmacokinetic drug-drug interactions were not observed in studies of.....Tighten the rotating hemostatic valve to secure the stent delivery system to the guiding.....on the product label may result in a ruptured balloon with possible intimal damage and..
http://www.fda.gov/cdrh/pdf3/P020026c.pdf (score=30)

Enforcement Report for April 14, 2004
...The FDA Enforcement Report is published weekly by the Food and Drug Administration.....The product was distributed directly to small Asian retail markets in states east of the.....Blood products, collected from a donor previously deferred due to history of IV drug use..
http://www.fda.gov/bbs/topics/enforce/2004/ENF00843.html (score=28)

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