When Is a Medical Product Too Risky? An Interview with FDA's Top Drug Official
...People can be seriously harmed by drug-drug interactions, and if they're going to a bunch of.....Heart valve disease is not known, in general, to be a side effect of pharmaceuticals, and.....Among the most widely publicized examples of recent drug withdrawals are the diet drug fenfluramine and the painkiller..
http://www.fda.gov/fdac/features/1999/599_med.html (score=100)

Human Drug Notes
...The CGMP regulations promulgated under the Food, Drug, and Cosmetic Act 5 HUMAN DRUG CGMP NOTES June, 1995 and codified.....valve and external examination, labeling, coloring, correct valve, etc. Finally, the firm.....Is the sale of expired OTC drugs by a retailer a violation of the Food, Drug and Cosmetic..
http://www.fda.gov/cder/hdn/hdn695.htm (score=100)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....stem orifice of the valve, the vapor pressure in the container, and the nature of the.....The guidance sets forth information that should be provided to ensure continuing drug..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=99)

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.....problems associated with the valve, the valve seal material, ejection of valve stems, the container.....Drug product containers and closures play a critical role in assuring that the drug..
http://www.fda.gov/cder/dmpq/freshair.htm (score=97)

Packaging
...Complete construction, composition, and description of all component parts of valve closure and container, including valve.....Arthur Shaw, Food and Drug Administration, for a Course offered by the Center for.....When drugs are administered by means of an aerosol dosage form, the valve closure system..
http://www.fda.gov/cder/guidance/package.htm (score=96)

Guidance for Industry
...valve assembly, the acceptability of the valve packing and the valve seal used, the type.....adverse drug experience, which is required to be reported to the Food and Drug.....would examine whether any of the threads on the valve or on top of the valve stem are..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=95)

Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...The manifolds are equipped with fill connections that correspond only to the container.....63 requires that equipment used in the manufacture, processing, packing, or holding of a.....The use of manifold and container valve connections recommended in the Compressed Gas..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=94)

[Drug Name]
...aberrant origin of coronary artery, bicuspid aortic valve, idiopathic hypertrophic.....Unusual and unexplained accumulation of drug resulting in toxic levels during usual.....Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570 .. Druginfo@cder.fda.gov..
http://www.fda.gov/cder/drug/InfoSheets/HCP/AdderallHCPSheet.pdf (score=94)

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.....In one system this occurred, due to malfunction of the feedwater valve and level control..
http://www.fda.gov/ora/inspect_ref/igs/high.html (score=94)

...This document is not intended to spell out how to conduct a CGMP drug inspection or set.....b) Microprocessors can be used for controlling a steam valve, maintaining pH, etc. They.....OVERVIEW When a computer system is first encountered in a drug establishment, it may be..
http://www.fda.gov/ora/inspect_ref/igs/csd.html (score=93)

Safety-Based Drug Withdrawals, 1997-2001
...Phenylpropanolamine was in use prior to 1962, when an amendment to food and drug laws.....Raplon (rapacuronium bromide) Injectable anesthesia drug administered as a muscle relaxant.....Risk of heart valve abnormalities .. 1973 .. Wyeth-Ayerst Laboratories .. Redux..
http://www.fda.gov/fdac/features/2002/chrtWithdrawals.html (score=93)

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.....Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect on the.....The valve should repeatedly dispense the aerosolized drug in discrete, accurate, small..
http://www.fda.gov/cder/fdama/difconc.htm (score=93)

FR Notice - Human Cells, Tissues, and Cellular and Tissue-Based Products;...
...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 section now also clarifies that the referenced drug and device regulations apply if..
http://www.fda.gov/cber/rules/frtisreg011901.htm (score=92)

Human Cells, Tissues, and Cellular and Tissue-Based Products;...
...The interim final rule excepted human dura mater and human heart valve allografts.....The Food and Drug Administration (FDA) is correcting an interim final rule that published.....McKeever, Center for Biologics Evaluation and Research (HFM-17), Food and Drug..
http://www.fda.gov/cber/rules/frtisreg013004.htm (score=92)

/a/content.19792
...Although valvular lesions were observed on both sides of the heart, a left-sided valve was.....Division of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and..Research.....incompetence, the prevalence of valve lesions was assessed for patients who were..exposed..
http://www.fda.gov/cder/news/mmwr.pdf (score=92)

...Human Heart Valve June 21, 1991 Do Do Allografts Draft Premarket Notification Review June.....Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain.....htm Division Guidelines for the Evaluation April 18, 1984 Do Drug Information Branch of..
http://www.fda.gov/cber/gdlns/guidelst.txt (score=91)

FDA Updates--July-August 2000 FDA Consumer
...The laser changes the drug's molecular shape in such a way that the drug stops or slows.....Scientists believe GERD develops when the muscular valve at the lower end of the esophagus.....Vancomycin has long been the drug of last resort in treating infections resistant to other..
http://www.fda.gov/fdac/departs/2000/400_upd.html (score=91)

Jurisdictional Update: Metered Dose Inhalers, Spacers and Other Accessories
...MDIs consist of a pressurized canister containing a drug substance and possibly excipients.....valve utilized in the product. For dose counters to provide accurate information, the.....Spacers will alter drug delivery characteristics to some extent, but do not specifically..
http://www.fda.gov/oc/combination/mdiupdate.html (score=91)

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.....In others, drug or preservative was not completely dissolved and was lying in the "dead..
http://www.fda.gov/ora/inspect_ref/igs/oral.html (score=91)

/a//content.15891
...healthy volunteers, any CNS active drug has the potential to impair judgment,thinking or.....ultrasound testing to carefully look at heart valve structure and function. In one study.....or feelings that make you concerned about your health or a possible drug side effect.Let..
http://www.fda.gov/cder/foi/label/2001/20632s8s11LBL.pdf (score=90)

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