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.....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)

...However, the ultimate responsibility for suitability of equipment used in drug processing rests.....TERMINAL A device, usually equipped with a CRT display and keyboard, used to send and.....This document is not intended to spell out how to conduct a CGMP drug inspection or set..
http://www.fda.gov/ora/inspect_ref/igs/csd.html (score=91)

FDA, Regualtory Delegations of Authority
...device used outside a user facility, any of the following officials are authorized to require a.....j) The Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review.....For any class II or class III device (including any device that is or contains a drug or..
http://www.fda.gov/smg/1410_415.htm (score=1)

Regulation of Medical Devices: Background Information for International...
...which is intended to be a life sustaining or life supporting device used outside a device user.....The request can recommend classifying the product as a drug, biological product, device.....which is intended to be a life-sustaining or life-supporting device used outside a device user..
http://www.fda.gov/cdrh/manual/ireas.html (score=0)

Criteria for Significant Risk Investigations of Magnetic Resonance...
...FDA believes that a magnetic resonance diagnostic device used under any one of the operating.....This guidance represents the Food and Drug Administration's (FDA's) current thinking on.....Generally, FDA deems magnetic resonance diagnostic devices significant risk when used..
http://www.fda.gov/cdrh/ode/guidance/793.html (score=0)

New Success Against Stroke-- Prevention, Improved Therapies Help Fight This...
...Also under study is a spring-like device used to prop open blood vessels after blockages are.....So before the drug is used, medical professionals must rule out hemorrhagic stroke by.....Several drug treatments, including one designed to stop the rapid death of brain cells..
http://www.fda.gov/fdac/features/1998/298_stroke.html (score=0)

MedWatch - 2004 Safety Information Alerts
...In vitro drug metabolism studies suggest that there is a potential for drug interactions.....This laboratory analyzer is used by laboratory professionals to measure thyroid hormones.....The device contains a 22mm x 22mm adapter made, and recalled, by Unomedical, who has found..
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm (score=0)

Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical...
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise.....For cross-labeling of products intended to be used together, often a drug may be used with several different devices, but the.....Kruskal described many other possibilities for combined drug/device or biologic/device..
http://www.fda.gov/oc/combination/workshop070803.html (score=0)

DRUG INFORMATION ASSOCIATION
...For a device being used with a branded proprietary drug, there should be collaboration between the.....You are not always going to be aware of whether there is a drug-device or a drug-biologic or a.....So, for example, an infusion pump is a device used in a healthcare facility to pump fluids into a..
http://www.fda.gov/oc/combination/presentations/dia/transcript.html (score=0)

TESTIMONY OF DAVID A. KESSLER, M.D., FEBRUARY 21,1996
...Take the case of the soft tissue fixation device used in orthopedic surgery, the device was on.....We must determine if each new drug or device is safe enough in view of its anticipated.....Will the drug that's sold deliver the same amount of drug as the drug used in the clinical..
http://www.fda.gov/ola/1996/nktest.html (score=0)

Perspectives from the FDA by Stuart L. Nightingale
...THE NAMES AND ADDRESSES OF IRBS ARE INCLUDED WHEN SPONSORS FILE INVESTIGATIONAL NEW DRUG APPLICATIONS AND INVESTIGATIONAL DEVICE.....USED FOR PREMARKET APPROVAL APPLICATION SUBMISSIONS TO FDA, FORCED US TO CAREFULLY.....A CHARACTERIZATION OF DRUG EFFECTS BY GENDER MUST NOW BE PART OF ALL NEW DRUG APPLICATIONS..
http://www.fda.gov/bbs/topics/SPEECH/SPE00061.htm (score=0)

FDA Enforcement Report
...PRODUCT Amiloride HCl and Hydrochlorothiazide 5 mg/50 mg, in bottles of 100 and 1,000.....REASON Lack of assurance of bioequivalence and abbreviated new drug application.....801, a medical device designed for the instillation and aspiration of fluid for lavage..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00145.html (score=0)

Senate Testimony Before the Senate FY 2002
...Most recently, FDA has approved the first non-invasive device used to detect trends and track.....As the Acting Principal Deputy Commissioner for the Food and Drug Administration, I.....NARMS data have been used to initiate field investigations of outbreaks of illness marked..
http://www.fda.gov/oc/oms/ofm/budget/2002/senatefinalwritten.htm (score=0)

MedWatch - 2003 Safety Information Alerts
...Based on the findings of the study, it was recommended that the AneuRx Stent Graft be used.....Patients with epilepsy who do not receive their antiepileptic drug due to a dispensing.....A component of the in-vitro diagnostic device was incorrectly installed causing false..
http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm (score=0)

41 final.qxd
...Food and Drug Administration has received medical device adverse event reports of vision.....increased intraocular pressure from the nitrous oxide used in general anesthesia during.....of 1990, the Medical Device Amendments of 1992, and the Food and Drug Administration..
http://www.fda.gov/cdrh/fusenews/ufb41.pdf (score=0)

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