Search Results
Results 51 - 100 of 386
1 2 3 4 5 6 7 8 >
Janda Michel - - 2009
Over the last decade, the use of computers and robotics in medicine has increased commensurate with emergent advances in technology. This article largely focuses on the challenges that the U.S. Food and Drug Administration faces when evaluating new technologies for entry into the market. How different categories of devices are ...
Pawlicka A - - 2009
Electrochromic devices (ECD) are systems of considerable commercial interest due to their controllable transmission, absorption and/or reflectance. For instance, these devices are mainly applied to glare attenuation in automobile rearview mirrors and also in some smart windows that can regulate the solar gains of buildings. Other possible applications of ECDs ...
Basile Edward M - - 2009
With no communication to industry except court filings in United States v. Undetermined Quantities of Boxes of Articles of Device (Shelhigh) and a draft guidance document, the Food and Drug Administration (FDA) has articulated new policies regarding export of pharmaceutical products and medical devices. FDA's departure from its historic interpretation ...
Fujioka Kouki - - 2009
Smell provides important information about the quality of food and drink. Most well-known for their expertise in wine tasting, sommeliers sniff out the aroma of wine and describe them using beautiful metaphors. In contrast, electronic noses, devices that mimic our olfactory recognition system, also detect smells using their sensors but ...
- - 2008
The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms ...
- - 2008
The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act ...
Rulis Alan M - - 2009
Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a ...
Surprenant Jennifer A - - 2008
Should the Food and Drug Administration (FDA)'s determination that a product is safe negate a private litigant's cause of action under state law in all circumstances, unless the FDA determines that the manufacturer withheld relevant information regarding the safety of the product? This Note concludes that such federal preemption is ...
Kennedy J F - - 2008
The Publisher regrets that this article is an accidental duplication of an article that has already been published in Int. J. Biol. Macromol., doi:10.1016/j.ijbiomac.2008.09.005. The duplicate article has therefore been withdrawn.
Park Sung-Hae - - 2008
The dye-sensitized solar cell (DSSC) devices using polymer electrolytes based on electrospun poly(vinylidene fluoride-hexafluoro propylene) (PVDF-HFP) nanofibers were fabricated and investigated the photovoltaic performances. The electrospun PVDF-HFP nanofibers were prepared by various parameters such as; polymer concentrations, applied voltages, and tip to collector distances (TCD) by the electrospinning method. The ...
- - 2008
The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule (IFR) that amended the regulation authorizing a health claim on soluble fiber from certain foods and risk of coronary heart disease (CHD), to add barley betafiber as an additional ...
Choudhry Shazia - - 2008
The 'best interests' standard is a highly seductive standard in English law. Not only does it appear to be fairly uncontroversial but it also presents as the most sensible, objective and 'fair' method of dealing with decision making on behalf of those who are perceived to be the most vulnerable ...
Dzanis David A - - 2008
Pet foods on the market that are contaminated or otherwise present a health risk to humans or animals may be subject to a recall under US Food and Drug Administration (FDA) regulations. Legally, all recalls are "voluntary," but there is little incentive for companies to refuse a request by FDA ...
Tan Jack Wei Chieh - - 2008
Endovascular treatment of infrarenal abdominal aortic aneurysm (AAA) offers a less invasive alternative to conventional open repair. Currently, only four devices are Food and Drug Administration (FDA)-approved for use in endovascular aneurysm repair (EVAR) of AAA in the United States. All four devices are associated with a high technical success ...
- - 2008
The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays." The agency is classifying the device into ...
Kulrattanarak T - - 2008
Membrane processes are well-known for separating and fractionating suspensions in many industries, but suffer from particle accumulation on the membrane surface. Currently, there are new developments using microfluidic devices for cell/DNA sorting and fractionation. We anticipate these devices are also applicable to fractionation of polydisperse and concentrated suspensions (e.g. foods), ...
Collins George W - - 2008
A simplified apparatus is described that measures the damping of a suspended measuring device. The movement of the device (bob) is damped by the properties of the air-water surface adsorbed material. Its value lies in describing the surface chemomechanical properties of ingredients and excipients used in food, nutraceutical, cosmetic (cosmeceutical), ...
- - 2008
OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by ...
Donawa Maria E - - 2008
Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k).
Gammie Alistair James - - 2008
It cannot be disputed that in-house ('home brew') assays have a part to play in the diagnosis of emerging or evolving infections such as avian influenza H5N1. In such circumstances, diagnostic companies can provide Research Use Only (RUO) or analyte specific reagents (ASR) to facilitate development. In contrast, the provision ...
Zarek Sarah - - 2008
Since 1997, the US Food and Drug Administration has approved 5 global endometrial ablation (GEA) devices for the minimally invasive treatment of idiopathic menorrhagia. These include a variety of modalities to ablate the endometrium, including thermal balloon, circulated hot fluid, cryotherapy, radiofrequency electrosurgery, and microwave energy. Level I evidence is ...
- - 2008
The Food and Drug Administration (FDA) is amending the health claim regulation entitled "Soluble fiber from certain foods and risk of coronary heart disease (CHD)" to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase ...
Di Chong-an - - 2008
We report high performance organic field-effect transistors (OFETs) with the modified Cu bottom-contact electrodes. Efficient modification of the Cu electrodes with nanometer-size copper tetracyanoquinodimethane (Cu-TCNQ) increases the electrode/organic layer contact area and reduces contact resistance. We investigated the effect of the Cu-TCNQ morphology on the device performance. The pentacene-based OFETs ...
- - 2008
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical ...
- - 2008
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ...
Vaughan Winston C - - 2008
PURPOSE OF REVIEW: Sinus surgery tools are constantly being developed. This review will focus on new devices (popularly called sinuplasty) for use in ostial dilation. RECENT FINDINGS: Balloons for sinus ostial dilation are approved by the Food and Drug Administration and are used worldwide. There have been presentations, publications and ...
Degnan Frederick H - - 2008
Probiotics are living microorganisms that, when consumed, have the potential to confer a beneficial health effect. Unfortunately for purveyors of probiotic products, the system of regulation delineated in the Food, Drug, and Cosmetic Act is anything but "one size fits all." How a probiotic product is used or is intended ...
Bray George A - - 2008
At any one time large numbers of people are attempting to control their weight. Women are the principal consumers of weight-control programs. Their options, outside the prescription drug market and surgical treatment, include diets and diet books, exercise alone or with supervision in exercise facilities, dietary supplements, group programs, doctors, ...
Lee Yu-Chi - - 2008
Chopsticks are popular dining utensils in many Asian countries. It is well recognized that the pincers-pinching mode has been recommended for chopsticks operation for Chinese dining. The objective of this study was to propose an auxiliary device for transferring the subjects who had experienced scissors pinching to that of pincers ...
Weerasinghe Manjula - - 2008
BACKGROUND: Self-poisoning with pesticides is the cause of an estimated 300,000 deaths annually in rural Asia. The great majority of these deaths are from impulsive acts of self-harm using pesticides that are readily available in the home. The secure storage of pesticides under lock has been emphasized as a possible ...
Horiuchi Akira - - 2008
BACKGROUND AND AIMS: Colonoscopy is an excellent but imperfect modality for colorectal cancer screening and prevention. We studied the effects of a retractable transparent extension device on adenoma detection rate as well as on intubation and withdrawal times. METHODS: Colonoscopy with or without the transparent retractable extension (TRE) was performed ...
Burbano Rommel R - - 2007
The Publisher regrets that this article is an accidental duplication of an article that has already been published in Food Chem. Toxicol., 46 (2008) 1205, doi:10.1016/j.fct.2007.10.019. The duplicate article has therefore been withdrawn.
Boyd Derek - - 2007
The Food and Drug Administration (FDA) has developed a new method for assessing food safety in retail establishments using a risk factor-based approach for prevention of foodborne illness. The study reported here surveyed facilities in the Navy's San Diego jurisdiction (11 fast-food and 22 full-service facilities) to establish a baseline ...
McHughen Alan - - 2008
This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In ...
Huff James - - 2007
The U.S. Food and Drug Administration (FDA) should reevaluate its position on aspartame as being safe under all conditions. Animal bioassay results predict human cancer risks, and a recent animal study confirms that there is a potential aspartame risk to humans. Aspartame is produced and packaged in China for domestic ...
Laurindo J B - - 2007
Vacuum impregnation (VI) is a food processing method by which air and native solution are removed from porous spaces within a food and replaced by an external solution. In this study, an experimental device based on a previous design was built, including some modifications, in order to investigate the dynamics ...
Walters Glenn D - - 2007
A taxometric analysis of the Psychopathy Checklist-Revised (PCL-R) is conducted on a group of 409 male maximum-, medium-, and minimum-security federal prison inmates using the four PCL-R facet scores (interpersonal, affective, impulsive lifestyle, and antisocial behavior) as indicators. Results obtained from three quasi-independent taxometric procedures-mean above minus below a cut, ...
Pumera Martin - - 2007
Different methods for construction of contactless conductivity detectors (CCD) for microchip electrophoresis device are described in this review. This includes three main schemes of CCD for microchips, such as (i) the detection electrodes are placed along the microchannel from outside of the microchip and they are insulated from the channel ...
- - 2007
The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," published elsewhere in this issue of the ...
Papadopoulos Stella - - 2007
Heparin-induced thrombocytopenia (HIT) is an immune-mediated complication that can occur after exposure to heparin products. Because patients with HIT are at increased risk for thrombosis, anticoagulation is warranted. The direct thrombin inhibitors lepirudin and argatroban are approved by the United States Food and Drug Administration (FDA) for this indication. Bivalirudin, ...
- - 2007
The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor ...
- - 2007
The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized ...
Tombelli Sara - - 2007
Aptamers are single stranded DNA or RNA ligands which can be selected for different targets starting from a huge library of molecules containing randomly created sequences. Aptamers have been selected to bind very different targets, from proteins to small organic dyes. In addition to the very important aspect of having ...
Boulos Paul J - - 2007
Various types of semi-adjustable articulators (arcon and nonarcon), in combination with different interocclusal recording materials (wax and polyether), have been proposed as an easier alternative to extraoral tracing devices or axiographs. There is no consensus as to which combination is the nearest to the recognized standard extraoral tracing devices. This ...
Tran Anh T K - - 2007
Two types of solid-phase materials, a styrenedivinylbenzene copolymer sorbent (embedded in a SDB-XC Empore disk) and a styrenedivinylbenzene copolymer sorbent modified with sulfonic acid functional groups (embedded in a SDB-RPS Empore disk), were compared as a receiving phase in a passive sampling device for monitoring polar pesticides. The SDB-XC Empore ...
Rarick Lisa - - 2007
This paper presents information about U.S. Food and Drug Administration (FDA) considerations for intrauterine progestins as part of a hormone replacement therapy strategy. Current U.S.-approved intrauterine systems are reviewed as well as FDA formal guidance to industry regarding clinical evaluation of combination hormone products. The formal guidance is contrasted with ...
Segovis Colin M - - 2007
Evidence suggests that attendance at medical grand rounds at academic medical centers is waning. The present study examined whether attendance at medical grand rounds increased after providing complimentary food to attendees and also assessed attendee attitudes about complimentary food. In this prospective, before-and-after study, attendance at medical grand rounds was ...
Gill Michelle - - 2006
We tested reproducibility of exhaled nitric oxide (FE(NO)) and inter-operator handling when measured with a handheld device, NIOX MINO. We enrolled 20 volunteers using a priori goals of acceptable reproducibility to be mean within-subject standard deviation less than 3 parts per billion (ppb) for FE(NO) measurements less than 30 ppb, ...
Anderson Rockford C - - 2006
The use of inferior vena cava (IVC) filters is increasing rapidly, and the recent availability of retrievable IVC filters is certain to accelerate this process. Unfortunately, because the risks and benefits of these devices have not been adequately studied, several important issues remain. Limitations of the quality of the data ...
Keida Tomoko - - 2006
The American Food and Drug Administration (FDA) bioequivalent guidance of topical dermatological corticosteroids in 1995 (the Guidance) requires measurement of the skin blanching response with a chromameter for evaluation of cutaneously applied corticosteroid formulations. The Japanese government decided to apply the same guidelines in 2003, despite there having been no ...
1 2 3 4 5 6 7 8 >