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Regulatory in Medical News

Warner Chilcott Reports Operating Results for the Quarter Ended June 30, 2009 and Updates 2009 Full Year Guidance

... facility to produce our products or production or regulatory problems with either third party manufacturers ... with whom we do business to obtain necessary regulatory approvals; our ability to manage the growth of ... such new products; our ability to obtain regulatory approval and customer acceptance of new products, ...

Labopharm Reports Results for Second Quarter Fiscal 2009

... on Friday, July 24, 2009. Submitted regulatory Application in Canada - Labopharm filed a new ... treatment of major depressive disorder, is under regulatory review in the U.S. by the FDA. The Company also ... including the uncertainties related to the regulatory process in various countries for the approval of ...

Blue Cross Blue Shield of Michigan, Michigan Attorney General and Michigan Office of Financial and Insurance Regulation Near Agreement on Rate Increases on Under Age 65 Individual Products

... of people seeking their own coverage and a broken regulatory system that requires BCBSM to cover all ... conditions. Another problem with the regulatory system is the amount of time it takes for rates ... health care companies operating in the broken regulatory system. BCBSM insures older, less healthy ...

Orexigen(R) Therapeutics Announces Second Quarter 2009 Financial Results

... conferences, peer-reviewed journals and regulatory agencies. These results build ... Michael Scaife, Ph.D. as Senior Vice President of regulatory Affairs and Product Development, Contrave ... served as Senior Vice President of Global Safety, regulatory Affairs and Quality for Chiron Biopharma, and in ...

Bipartisan Panel of Industry, NGO and Academic Experts Proposes New Rules for Science in Federal Regulation

... -- A bipartisan panel of top scientific and regulatory experts today released recommendations calling on ... federal agencies to make specific changes in the regulatory process to clearly distinguish scientific ... "Our recommendations would make the regulatory process more rigorous and transparent," said ...

Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers

... all data sources available to them, and work with regulatory agencies to update the label as appropriate based ... metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and ... for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past ...

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Regulatory in Medical Technology

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... alfa program from both a clinical and regulatory perspective," said Sylvie Gregoire, President of ... to work diligently with the FDA and other regulatory agencies to make velaglucerase alfa available as ... by both the physicians and patients." regulatory Updates With regard to ongoing ...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

... to differing interpretations, and the views of regulatory agencies, medical and scientific experts and ... of data and other information that may affect regulatory review and commercialization of BZA/CE. There can be no assurance that BZA/CE will ever receive regulatory approval or be successfully developed and ...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

... but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that ... of clinical trial data by the FDA in support of regulatory approval; and the tolerability profile and/or ... prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to ...

Lilly and New York City Mayor Michael R. Bloomberg Announce Lilly Agrees to be First Tenant of East River Science Park; Issue Urgent Call for Healthcare Reform that Protects Innovation and Jobs

... uncertainties in the process of development and regulatory review. There is no guarantee that the products will receive regulatory approval, or that the regulatory approval will be for the indications anticipated ...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

... by these patients. The EMEA is a regulatory agency in the European Union (EU) primarily ... the EU include 10 years of marketing exclusivity, regulatory assistance, reduced regulatory fees associated with applying for marketing ...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

... once weekly is not currently approved by any regulatory agencies. Amylin Pharmaceuticals is a ... filings, not being submitted in a timely manner; regulatory approval, including approval for exenatide once ... the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the ...

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Regulatory in Medical Products

MasterControl Quality Management Software Suite

Description:... and provides all the essential building blocks to construct any regulatory or quality management system to boost operational efficiency, improve product quality, and drive compliance with regulatory and quality standards. Click here to learn about viewing a pre-recorded ...
Company:MasterControl, Inc.

HEMOCHRON Response Coagulation Monitoring Instrument

Description:... an easy-to-read screen and data management features, including patient and operator ID options. QC and operator lockout can be enabled for enhanced regulatory ....
Company:ITC

21 CFR Pharma

Description:... proposals and final rules published in the Federal Register. Content is updated regularly as released by the Government Printing Office. Need-to-know regulatory information on human ....
Company:Unbound Medicine, Inc.

StatStrip Glucose Monitoring System

Description:... in easy sample acquisition and minimal pain for the patient. Comprehensive instrument manager software provides management, control, and regulatory compliance, and allows the StatStrip system to be completely customized to the needs of each department within the ....
Company:Nova Biomedical

Dairylands Health Information Management

Description:... Management solutions provides healthcare organizations a suite of integrated applications for managing patient records, optimizing reimbursement and regulatory ....
Company:Dairyland Healthcare Solutions

ophthalmicsuiteASC Ambulatory Surgery Software

Description:... supported on tablet PC technology permitting multiple people to access or enter data simultaneously. Process control for record keeping, billing and regulatory compliance reporting is standard. The ASC module also provides inventory control and management option. It is compatible with bar coding ....
Company:Medflow Inc.

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Regulatory in Medical Definition

Medical writing

... professionals known as medical writers is either regulatory medical writing or educational medical writing . regulatory writing is writing documents for regulatory agencies so that drugs, devices and biologics are ...

Thymocyte

... Single positive CD4+CD8- or CD4-CD8+ medulla Negative selection, regulatory T cell conversion Events during maturation type: ... periphery exist to silence these cells such as anergy , deletion, and regulatory T cells . If these peripheral tolerance mechanisms also fail, ...

Central tolerance

... ( apoptosis ) Anergy (non-responsiveness) Receptor editing (changing the specificity of the autoreactive cell) [4] Division to a regulatory lineage Genetic defects in these processes lead to autoimmunity, such as in the human syndromes APS-1 and IPEX . References ...

Medicine

... practice ( Internship and/or Residency ) and possibly postgraduate vocational training. Continuing medical education is a requirement of many regulatory authorities. Various teaching methodologies have been utilised in medical education, which is an active area of educational research. Presently, ...

Personalized medicine

... Senator Barack Obama introduced the Genomics and Personalized Medicine Act to overcome the scientific barriers, adverse market pressures, and regulatory obstacles that have stood in the way of better medicine. [1] In addition, in the United States. The Secretary of Health and Human Services Mike ...

Telephone Triage

... and expertise from a multi-national and multicultural perspective. Accreditation in the future will likely be 80 hours of formal training through a regulatory agency, like AAACN. Core content will include telemedicine and telemetry, competency training, medical decision-making theory, legal aspects, ...

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Regulatory in Medical Dictionary

Genes

... nonpolyposis colorectal cancer (HNPCC). regulatory GENES : As related to HIV regulatory T CELLS: T cells that direct other immune cells to perform special functions. The chief regulatory cell , the CD4 cell or T helper cell , is ...

Death

... an overdose are: ... NECROSIS : Death of tissue . NEF: One of the regulatory genes of HIV . Three HIV regulatory genes -[html removed]tat[html removed], [html removed]rev[html removed], ....

Medulla oblongata

... adjacent to the spinal cord. Houses important cardiac and respiratory regulatory centers. [ Med Help International ] [ Search ] [ Ask the Doctor Forums ] ... cord. The medulla is the site of important cardiac and respiratory regulatory centers. Opioid ... ventro lateral medulla oblongata micro vascular ...

Necrosis

... and finger weakness . NECROSIS : Death of tissue . NEF: One of the regulatory genes of HIV . Three HIV regulatory genes -[html removed]tat[html removed], [html removed]rev[html removed], ....

Acid

... of nucleic acid (DNA and RNA). Arachidonic Acid Arachidonate An essential, unsaturated, 20 carbon fatty acid that humans use to synthesize regulatory molecules such as prostaglandins and thromboxanes. Acid reflux is one cause of gastroesophageal reflux disease (GERD). GERD may have other ...

Confusion

... temporary and reversible. Disorders that cause delirium are numerous and varied. Confusion , contradiction, and/or lack of consistency in regulatory language is a big challenge for all health care professionals. In the case of EMTALA, the language as it relates to other qualified medical personnel ...

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Regulatory in Biological News

Carnegie Mellon team makes sequestration recommendations

... new federal regulations that create a uniform regulatory environment. This is the conclusion of a set of ... federal law and agency rules needed to overcome regulatory and legal barriers to large-scale deployment of ... facilities before finalizing many of the regulatory details. For this reason, developing an "adaptive ...

Stanford researchers publish comprehensive model for medical device development

... devices that may be exempt from most regulatory requirements. The five major phases and decision ... of the advent of advanced technologies, stricter regulatory requirements, and the increasing importance of ... and brought to market. The pace at which such regulatory requirements can be met determines when the ...

Trio of signals converge to induce liver and pancreas cell development in the embryo

... along the correct path is provided by genetic regulatory proteins that attach to chromosomes, marking part ... nucleus of every cell must be loosened a bit. The regulatory proteins help with this, exposing a small domain ... progenitor cells to activate genes encoding the regulatory proteins. ...

They are young and need the job: A second chance for dangerous T-cells

... T-cells are very readily reeducated into regulatory T-cells. Under identical conditions, however, ... from blood. Possibly, they could then be used as regulatory T-cells in therapies for autoimmune diseases such ... Some of them are 'reeducated' into so-called regulatory T-cells. While these still possess a T-cell ...

Notre Dame researchers describe new tool for evaluating 'managed relocations'

... harming the new ecosystem, existing and potential regulatory context for translocation, and the social and ... since 2005, Camacho specializes in the study of regulatory innovation in environmental and land use la,w including the adaptation of regulatory institutions in response to climate change. ...

The evolution of gene regulation

... for more detailed studies of the evolution of regulatory systems." ( PNAS Early Edition, 22 Mai 2009) ... minimal use of the proteins. "The evolution of regulatory systems is still barely understood," reports ... may now prove to be an important factor in regulatory development. Many questions are still open, and ...

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Regulatory in Biological Technology

KV Pharmaceutical Announces Stockholder Action to Amend By-Laws is Invalid

... product development, product launches, regulatory approvals, market position, acquisitions, sale of ... arrangements with third parties; (10) the regulatory environment, including regulatory agency and judicial actions and changes in ...

NeurogesX Reports Second Quarter 2009 Results

... requests and successfully navigating the European regulatory processes to gain marketing approval in the ... in order to focus on activities related to regulatory reviews in the United States and European Union. ... our cash resources towards achieving U.S. regulatory approval of Qutenza and conducting ...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... development timelines and the likelihood of regulatory success. All forward-looking statements and other ... trials and there can be no assurance that the regulatory authorities in either the United States or Europe will grant regulatory approval based upon this data, in combination ...

Curis and Debiopharm Sign an Exclusive License Agreement Covering the HSP90 Inhibitor CUDC-305

... achievement of specified clinical development and regulatory approval objectives as well as royalties ... drug delivery and formulation, and regulatory affairs. Founded in 1979 and headquartered ... delays in obtaining or maintaining required regulatory approvals for products under development ...

Angiotech Pharmaceuticals, Inc. announces financial results for the second quarter ended June 30, 2009

... expenses and other current assets. New TAXUS regulatory Approvals and Clinical Data. In July 2009, we ... 30, 2009 and 2008 will be filed with the relevant regulatory agencies, as well as posted on our website at ... and the timing of decisions, made by health regulatory agencies regarding approval of our technology and ...

NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application

... but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that ... analysis or information by the FDA in support of regulatory approval; plans and timing for commercialization ... prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to ...

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Regulatory in Biological Products

Mouse Anti-PRKAR2 Monoclonal Antibody, Unconjugated, Clone RS17 from GeneTex

Description:... holoenzyme of AMPK is a tetramer composed of two regulatory and two catalytic subunits. cAMP causes the dissociation of the inactive holoenzyme into a dimer of regulatory subunits bound to four cAMP and two free monomeric catalytic subunits. Four different regulatory subunits and three catalytic subunits of AMPK ...
Company:GeneTex

Ubiquitin Fraction I Extract from GeneTex

Description:... of appropriate levels of short-lived and regulatory proteins as important and diverse as those ... which is crowned at one or both ends by 19S regulatory subunit complexes. The 19S regulatory subunits recognize ubiquitinated proteins and ...
Company:GeneTex

IRS Extract from GeneTex

Description:... of appropriate levels of short-lived and regulatory proteins as important and diverse as those ... which is crowned at one or both ends by 19S regulatory subunit complexes. The 19S regulatory subunits recognize ubiquitinated proteins and ...
Company:GeneTex

26S Proteasome Fraction Extract from GeneTex

Description:... of appropriate levels of short-lived and regulatory proteins as important and diverse as those ... which is crowned at one or both ends by 19S regulatory subunit complexes. The 19S regulatory subunits recognize ubiquitinated proteins and ...
Company:GeneTex

Ubiquitin Fraction I from ABR-Affinity BioReagents

Description:... of appropriate levels of short-lived and regulatory proteins as important and diverse as those ... which is crowned at one or both ends by 19S regulatory subunit complexes. The 19S regulatory subunits recognize ubiquitinated proteins and ...
Company:ABR-Affinity BioReagents

Ubiquitin/Proteasome Fraction II Extract from GeneTex

Description:... of appropriate levels of short-lived and regulatory proteins as important and diverse as those ... which is crowned at one or both ends by 19S regulatory subunit complexes. The 19S regulatory subunits recognize ubiquitinated proteins and ...
Company:GeneTex

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Regulatory in Biological Definition

Bioinformatics

... genes that code for proteins , as well as regulatory sequences. A comparison of genes within a ... analysis is the automatic search for genes and regulatory sequences within a genome. Not all of the ... (clustered together) genes to find common regulatory elements and used machine learning techniques ...

Bioinformatics

... genes that code for proteins , as well as regulatory sequences. A comparison of genes within a ... analysis is the automatic search for genes and regulatory sequences within a genome. Not all of the ... (clustered together) genes to find common regulatory elements and used machine learning techniques ...

Gene

... function , or small interfering RNAs have a regulatory role. The DNA sequences from which such RNAs are ... , to specific non-coding DNA sequences called regulatory elements . So, to be expressed, our DNA strand ... For example, natural variations within regulatory sequences appear to underlie many of the ...

Gene regulatory network

... A gene regulatory network (also called a GRN or genetic regulatory network ) is a collection of DNA segments in a ... the metaphor of Boolean networks to model genetic regulatory networks. Each gene, each input, and each ...

Insulin

... between species . Its carbohydrate metabolism regulatory function strength also varies. Pig insulin is ... 3 Actions on cellular and metabolic level 4 regulatory action on blood glucose 5 Signal ... that they may produce a secretion that plays a regulatory role in digestion. Insulin crystals ...

DNA

... of replication and transcription. These sequences are frequently called regulatory sequences , and researchers assume that so far they have identified only a ... of DNA and RNA strands. Segments of DNA that cells have methylated for regulatory purposes may adopt the Z geometry, in which the strands turn about the ...

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Regulatory in Biological Dictionary

Stringency

... you discuss stringency with your primary state regulatory ... Click on the first link on a line below to ... you discuss stringency with your primary state regulatory contact. ... Regulations | Kansas ... ... you discuss stringency with your primary state regulatory contact. ... reasonableness of increased ...

Regulatory sequence

... A regulatory sequence is a segment of DNA where regulatory proteins such as transcription factors bind preferentially. These regulatory proteins bind to short stretches of DNA called ...

Regulatory region

... A regulatory sequence is a segment of DNA where regulatory proteins such as transcription factors bind preferentially. These regulatory proteins bind to short stretches of DNA called ...

Operon

... and more. ... An operon is a genetic regulatory system found in ... The lac Operon - an ... including an ... The operon may also contain regulatory genes such as a repressor gene which ... ... that operon . ... The operon may also contain regulatory genes such as a repressor. Repressor ... Operon ...

Gene regulatory network

... A gene regulatory network or genetic regulatory network (GRN) is a collection of DNA segments in ... at which genes in ... A summary of gene regulatory networks , part of the science behind the ...

Allosteric site

... metabolism (biology): Fine control ) ... the regulatory sites have no obvious structural similarity to ... site . Implications for the allosteric regulatory mechanism ... Keywords: allosteric site , ... activator binds to the enzyme at the regulatory site , the ... will remain activated until the ...

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Other Contents
(Date:8/30/2014)... "My niece developed a nighttime fever, and I ... fever might get worse," said an inventor from Montgomery, ... how she was doing, I developed this monitoring system." ... a child's temperature. The unit instantly alerts parents if ... medical care can be given, which is designed to ...
(Date:8/30/2014)... 2014 The federal judge overseeing ... http://www.injurybeacon.com/transvaginal-mesh/ ) filed against Boston Scientific Corp. has ... selected for one of the proceeding’s bellwether trials. ... 2014, U.S. District Judge Joseph R. Goodwin of ... Boston Scientific’s contention that a consolidated trial would ...
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(Date:8/29/2014)... Researchers at UC Davis have made some surprising ... infection. Studying simian immunodeficiency virus (SIV), the team ... Paneth cells are early responders to viral invasion ... producing a cytokine called interleukin-1 beta (IL-1β). ... IL-1β causes breakdown of the gut epithelium that ...
(Date:8/29/2014)... ANTONIO (Aug. 29, 2014) Scientists at the Barshop ... School of Medicine at the UT Health Science Center ... in the tissues of the longest-lived rodent, the naked ... in the cells of naked mole rats protects and ... for damaged and obsolete proteins. , The factor also ...
(Date:8/29/2014)... recently, little has been known about what genetic changes ... of scientists, one of whom is a University of ... that genes controlling the development of the brain and ... The study was published Aug. 28 in Science ... is online at http://www.sciencemag.org/ ., The domestication of ...
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