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- - 2004
The Food and Drug Administration (FDA, we, our) is issuing a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the act) because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, ...
- - 2004
The Food and Drug Administration (FDA) is issuing an interim final rule to except human dura mater and human heart valve allografts, currently subject to application or notification requirements under the Federal Food, Drug, and Cosmetic Act (the act), from the scope of the definition of "human cells, tissues, or ...
Lessinger Jean-Marc - - 2004
Because routine assays for pancreatic lipase catalytic activity are not yet standardized, between-method comparability is very poor. This is mainly due to the lack of reference materials (RMs). The aim of this study was to assign values of catalytic concentration to two human pancreatic lipase RMs, one prepared from human ...
Baserisalehi M - - 2004
AIM: To design a special device which can be used with nonselective blood-free nutrient agar without enrichment for detection of campylobacters from water. METHODS AND RESULTS: The Kapadnis-Baseri device (KB device) was designed and evaluated in comparison with the conventional method (C method) for detection of Campylobacter spp. from river ...
- - 2004
The Food and Drug Administration issued a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the act) because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions ...
- - 2004
In November 1998, Novartis Pharma of Switzerland and SkyePharma PLC of the UK signed an agreement to jointly develop a new formulation of the beta(2)-adrenoceptor agonist formoterol (Foradil). The new product, Foradil Certihaler, utilises a multidose dry-powder inhaler (MDPI or MDDPI) device, SkyeHaler, developed by SkyePharma. It also utilises SkyePharma's ...
- - 2003
The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue ...
Barold Helen S - - 2003
The results of the MADIT II study have generated a great deal of controversy in the world of electrophysiology. Much of the controversy appears related to the sheer numbers of potential Implantable Cardioverter Defibrillator (ICD) implants and their potential cost to the healthcare system. Two federal regulatory agencies, the Food ...
Salinas Patricia C - - 2003
Netrin-1 is an attractive axon guidance molecule required for the proper navigation of commissural axons to the floor plate in the spinal cord. A new study now shows that sonic hedgehog (Shh) from midline structures collaborates with netrin-1 to guide commissural axons. This new role for the morphogen Shh raises ...
- - 2003
The Food and Drug Administration (FDA) is announcing final recommendations to revise the permitted daily exposures (PDEs) for two solvents, n-methylpyrrolidone (NMP) and tetrahydrofuran (THF), according to the maintenance procedures for the guidance for industry entitled "Q3C Impurities: Residual Solvents." The final recommendations were reached under the auspices of the ...
- - 2003
The Food and Drug Administration (FDA) is classifying the endotoxin assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the ...
- - 2003
The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments ...
Johnson Colena A - - 2003
The primary enclosure of a laboratory animal's environment should encourage species-typical behavior and enhancement of the animal's well-being, as indicated by the Guide. Enrichment devices have been documented to decrease the incidence of stereotypical behaviors and increase overall activity of rabbits. An 8-week study was performed to evaluate the effect ...
Barrett Stephen - - 2003
Federal agencies have never had enough resources to cope with the enormous amount of deception in the supplement and health-food marketplace. Passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) has worsened the situation by encouraging dubious claims and weakening the Food and Drug Administration (FDA)'s ability to ...
Ogden Neil - - 2003
Federal regulation of medical devices began in 1976 with the signing of the Medical Device Amendments to the Food, Drug and Cosmetic Act. For the purpose of regulating medical devices, the Food and Drug Administration is divided into various divisions and branches, including the Office of Device Evaluation. The evolution ...
- - 2003
The Food and Drug Administration (FDA) is classifying the breast lesion documentation system into class II (special controls). The special controls that will apply to this device are discussed later in this document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, ...
- - 2003
The Food and Drug Administration (FDA) is classifying the breath nitric oxide test system into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 ...
- - 2003
The Food and Drug Administration (FDA) is issuing a final rule to amend the classification regulations for eight surgical suture devices previously reclassified into class II to specify a special control for those devices. The special control is an FDA guidance document entitled "Class II Special Controls Guidance Document: Surgical ...
- - 2003
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a ...
Donawa Maria - - 2003
The United States Food and Drug Administration (FDA) has decided to reexamine its regulations for electronic records and signatures, and during this process, to reduce the enforcement of some of the provisions of the regulations. This article discusses FDA's decision and the content of its related, recently issued guidance document.
Campbell Kathleen C M - - 2003
This study describes audiologic methodology and results for evaluating potential ototoxicity in a phase I clinical trial of a new glycopeptide. This study was conducted under good clinical practices, which are regulated by the US Food and Drug Administration (FDA) (21 Code of Federal Regulations), and input from the FDA ...
Carroll J F - - 2003
Host-seeking activity of adult blacklegged ticks, Ixodes scapularis Say was monitored by flagging during winter months in Beltsville, MD. Ticks were active many days during January and February, the coldest months, with some captures made when there was 70% snow cover and temperatures as low as -2 degrees C. Substantial ...
Majolo Bonaventura - - 2003
The authors analyze the effects of enrichment devices on the behavior of common marmoset female pairs, and determine which aspects of these devices are more likely to elicit explorative behaviors, and how their presence affects aggressive and stress-related behaviors. The results support the use of enrichment devices for captive primates ...
- - 2003
The Food and Drug Administration (FDA) is reclassifying the automated blood cell separator (ABCS) device operating by filtration principle, intended for routine collection of blood and blood components, from class III to class II (special controls). The special control requirement for this device is an annual report with emphasis on ...
Berlutti Francesca - - 2003
OBJECTIVE: In this study we examine the efficacy of anti-retraction devices in preventing microbial contamination of dental unit water lines (DUWLs). METHODS: The study was performed on 54 randomly selected DUs in use at private and public institutions for over six months. The selected DUs were all currently commercially available. ...
Fiume Monice Zondlo - - 2003
Triacetin, also known as Glyceryl Triacetate, is reported to function as a cosmetic biocide, plasticizer, and solvent in cosmetic formulations, at concentrations ranging from 0.8% to 4.0%. It is a commonly used carrier for flavors and fragrances. Triacetin was affirmed as a generally recognized as safe (GRAS) human food ingredient ...
Kimura S - - 2003
The purpose of this research is to design a device which can treat highway runoff, especially runoff during initial rainfall with high pollution intensity, by connecting it with the draining grid sink of a drainage ditch on a highway, through which runoff flows. Porous polypropylene (PPL) particles were used as ...
- - 2002
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Ethicon, Inc., reclassifying the absorbable polydioxanone surgical (PDS) suture intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ...
- - 2002
The Food and Drug Administration (FDA) is classifying the transcutaneous air conduction hearing aid system (TACHAS) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. The agency ...
Sudol Mark F - - 2002
Both permit requirements and ecological assessments have been used to evaluate mitigation success. This analysis combines these two approaches to evaluate mitigation required under Section 404 of the United States Clean Water Act (CWA) and Section 10 of the Rivers and Harbors Act, which allow developers to provide compensatory mitigation ...
Blumenthal Scott L - - 2002
This is a synopsis of a symposium presented to the North American Spine Society Annual Meeting in Seattle, WA, 2001. To bring to the reader who may not have attended the symposium a distillation of the material presented on this frontier of spinal surgery. Panel presentation. The proposed indication for ...
Zhang Ling-Zhi - - 2002
A new class of highly stable furan-based hole transporting oligomeric materials, synthesized from the corresponding propargylic dithioacetals, serve as efficient hole transporting materials in electroluminescent devices. The performance of the devices using these furan materials is comparable with or somewhat better than those employing the conventional triarylamines (e.g. alpha-NPD).
Badin Ana Zulmira Diniz - - 2002
An innovative liposuction technique using a laser device is presented. It is a precise method, less traumatic than the conventional one. The interaction between the laser and the adipocyte causes lipolysis with reduced bleeding and its effect on collagen tone promotes collagen retraction and skin shrinkage. The results of the ...
Oprea Tudor I - - 2002
ChemGPS, the chemical global positioning system, is a tool that combines rules (equivalent to dimensions) and objects (chemical structures) to provide a consistent chemical space map (Oprea, T. I.; Gottfries, J. J. Comb. Chem. 2001, 3, 157-166.). Rules included, initially, general properties such as size, lipophilicity, and hydrogen bond capacity, ...
- - 2002
The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data ...
Kingshott Ruth N - - 2002
The polysomnographic efficacy of a novel tongue-stabilizing device (TSD) in the treatment of snoring and sleep-disordered breathing (SDB) was evaluated in this pilot study. Six current users of the TSD with SDB underwent polysomnography with and without the TSD in situ in a randomized crossover design. The TSD significantly lowered ...
Abanov Ar - - 2002
Motivated by recent experiments by Basov et al., we study the differential sum rule for the effective scattering rate 1/tau(omega). We show that, in a dirty BCS superconductor, the area under 1/tau(omega) does not change between the normal and the superconducting states. For magnetically mediated pairing, a similar result holds ...
Cruz Helder J - - 2002
Immunosensors can play an important role in the improvement of veterinary diagnostics in areas such as the diagnosis of diseases, drug detection and food quality control, by providing applications with rapid detection, high sensitivity and specificity. Associated with advances in biochemistry, biotechnology, electronics and microfabrication, new transduction devices that translate ...
- - 2002
The Food and Drug Administration (FDA) is reclassifying the hip joint metal/polymer constrained cemented or uncemented prosthesis intended to replace a hip joint from class III (premarket approval) to class II (special controls). FDA is also [[Page 21172]] identifying the guidance document entitled "Class II Special Controls Guidance Document: Hip ...
- - 2002
The Food and Drug Administration (FDA) is reclassifying the endolymphatic shunt tube with valve from class III (premarket approval) into class II (special controls). The device is intended to be implanted in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in ...
- - 2002
The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to ...
- - 2002
The Food and Drug Administration (FDA) is classifying the ingestible telemetric gastrointestinal capsule imaging system device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, ...
- - 2002
The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood ...
- - 2002
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (116) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:Genotoxicity Testing" (VICH GL23). This final guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of ...
Levin Gilbert V - - 2002
Tagatose, a low-calorie, full-bulk natural sugar, has just attained GRAS (Generally Recognized As Safe) status under U.S. Food and Drug Administration (FDA) regulations, thereby permitting its use as a sweetener in foods and beverages. This paper presents all current aspects of tagatose with respect to demonstrated food and beverage applications ...
- - 2001
The Food and Drug Administration (FDA) is announcing the availability of guidance entitled "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use" (M4CTD). The guidance was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for ...
Moed L - - 2001
Cantharidin, a vesicant produced by beetles in the order Coleoptera, has a long history in both folk and traditional medicine. In dermatology, topical cantharidin has long been used to treat warts and molluscum. In 1962, cantharidin lost Food and Drug Administration (FDA) approval owing to the failure of its manufacturers ...
- - 2001
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes ...
Donawa M - - 2001
The United States Food and Drug Administration (FDA) has announced its intention to launch an extraordinary new pilot programme that could have a significant effect on efforts to harmonise premarket review procedures worldwide. This article discusses the programme and the importance of submitting comments to FDA on this new initiative.
Uchida T - - 2001
A 35-year-old man with constrictive pericarditis underwent pericardiectomy. The pericardium was dissected with a Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, OH). This new device has many advantages including no muscular stimulation, low heat, a smokeless field, and easy hemostasis. The Harmonic Scalpel is beneficial for dissection of thickened pericardium.
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