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Regulatory in Medical News

Novo Nordisk Appoints Per Falk, M.D., Ph.D., as Vice President for Clinical, Medical and Regulatory Affairs for North America

PRINCETON, N.J., Aug. 5 /PRNewswire-FirstCall/ -- Novo Nordisk, a global healthcare company focusing on diabetes care, today announced the appointment of Per Falk, M.D., Ph.D., as vice president for Clinical, Medical and Regulatory Affairs for North America. Dr. Falk joins the U.S. Executive ...

Validation & Compliance Institute, LLC, to Provide Medical Device Regulatory Training for the University of Michigan's Medical Innovation Center

ANN ARBOR, Mich., Aug. 3 /PRNewswire/ -- Validation & Compliance Institute (VCI) is developing a series of training videos for the University of Michigan Medical Innovation Center (MIC). The videos will introduce University of Michigan researchers to the regulations that are required by ...

CSC's FirstDoc Recognized by EMC as a Preferred Regulatory Compliance Application for Life Sciences Industry

FALLS CHURCH, Va., July 30 /PRNewswire/ -- CSC (NYSE: CSC ) today announced an agreement with EMC Corporation to offer advanced compliance solutions to the life sciences industry. As part of the agreement, EMC will now offer CSC's FirstDoc as a preferred regulatory compliance...

Cornerstone Therapeutics Submits Regulatory Filing for Extended-Release Antitussive Product

CARY, N.C., July 15 /PRNewswire-FirstCall/ -- Cornerstone Therapeutics Inc. (Nasdaq: CRTX ), a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that it has submi...

NeoStem, Inc. Appoints International Expert in Endocrinology and Pharmacology as Vice President of Drug Development and Regulatory Affairs

NEW YORK, July 6 /PRNewswire-FirstCall/ -- NeoStem, Inc. (Amex: NBS ), which is pioneering the pre-disease collection, processing and long-term storage of adult stem cells for future medical need, announced today it has appointed Alan G. Harris, M.D., Ph.D., FACP, FRCP, as the Company's Vice Pre...

Saint Vincent Health Center Ensures Regulatory Compliance with SIS

ATLANTA, June 23 /PRNewswire/ -- Each year hospital operating rooms face increasingly difficult challenges as patient safety requirements from regulatory agencies grow more demanding. Saint Vincent Health Center (SVHC) in Erie, PA uses a perioperative automation solution, Sunrise Surgery(TM), pro...

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Regulatory in Medical Technology

PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA

ANNAPOLIS, Md., May 22 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE Amex: PIP ), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that the Company has submitted its comprehensive regulatory strategy to the U.S. Food and Drug ...

TissueGene Announces Regulatory Allowance to Initiate Phase IIa Study of TG-C in South Korea for Osteoarthritis of the Knee

ROCKVILLE, Md., March 2 /PRNewswire/ -- TissueGene, Inc. announced today that its South Korean licensing partner Kolon Life Science, Inc. (KLS) has received regulatory allowance from the Korea Food and Drug Administration (KFDA) to initiate a Phase IIa clinical trial of TissueGene-C (TG-C) in pati...

Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV Compounds

- Not Intended for Journalists in the UK or Ireland - New Findings From ARTEMIS and TITAN Studies Demonstrate Growth of the Tibotec Virology Franchise GLASGOW, Scotland, Nov. 12 /PRNewswire/ -- New data on PREZISTA(R) (darunavir), a protease inhibitor from Tib...

IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)

IRVINE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI ) today announced that it met with representatives of the Committee for Medicinal Products for Human Use (CHMP) and Secretariat of the European Medicines Agency (EMEA) on September 25th, following the CHMP's Sep...

BioVex Announces Regulatory Clearance to Commence a Clinical Study With ImmunoVEX HSV2; A Vaccine Candidate for Genital Herpes

WOBURN, Mass., Aug. 20 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted BioVex's Clinical Trial Applicatio...

First Cancer Diagnostic Test Based on Rosetta Genomics' Proprietary MicroRNA Technology Receives Regulatory Approval

Test Developed and Validated by Columbia University Medical Center Based on Rosetta Genomics' Proprietary MicroRNA Technology The Test Differentiates Squamous From Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Classifying Squamous-Cell Carcinoma of the Lung With Sensitivity...
Regulatory in Medical Products

HEMOCHRON Response Coagulation Monitoring Instrument

Description:...es 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 compliance....
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 drugs....
Company:Unbound Medicine, Inc.

StatStrip Glucose Monitoring System

Description:...results 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 hospital....
Company:Nova Biomedical

Dairylands Health Information Management

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

ophthalmicsuiteASC Ambulatory Surgery Software

Description:...e 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 devices....
Company:Medflow Inc.

AVOXimeter 4000

Description:...lts are obtained in less than 10 seconds. Comprehensive data management, quality control, and readily available proficiency-testing materials make regulatory compliance quick and easy....
Company:ITC
Regulatory in Medical Definition

Central tolerance

...selection ( 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

...ised 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, i...

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 ...

Personalized medicine

...ers. 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 Leav...

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, speciali...

Thymocyte

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

Pda

...ave color screens and audio capabilities, enabling them to be used as mobile phones (smartphones), web... PDA provides scientific, technical and regulatory information on pharmaceutical and biopharmaceutical manufacturing and quality worldwide. PDA at the Cell Phone Shop. Find electronics, accessori...

Occupational therapy

... ... Offers content relevant to occupational therapy practitioners, including job listings, practice management, reimbursement, marketing, and regulatory information. GradSchools.com offers Occupational Therapy graduate school & program listings including masters, PhD and other Allied Heal...

Mutation

...e nucleotide sequence of an organism's DNA ... a result, the sickle-cell mutation persists in populations where malaria ... Mutations in key regulatory genes ( tumor suppressors and proto-oncogenes ) ... In order to generate a cancer cell, a series of mutations must occur in the same cell. ......

Mold

...aints so ... If a moldy smell can be detected, there is mold around. ... Mold Licensing Program ... Consumer Mold Information Sheet. DSHS regulatory Philosophy (pdf 21KB) Information About Mold Problems in Buildings. Licensing ... Mold Inspections and Mold ... Mold Remediation. Suggeste...

Hormone levels

...aded ... The thyroid also produces the hormone calcitonin, which plays a role in ... Iodothyronine levels in the human developing brain: major regulatory roles of ... estrogen is a hormone or chemical messenger produced in both men and women ... (oral contraceptives) take advantage of this effect ...

Generic

...fate 75-mg tablets (Plavix), and ... Today’s health care cost crisis is widely feared. In a shocking exposure, Life Extension uncovers a corrupt regulatory system that causes generic drug prices to be ... This article describes a concept which could impact a variety of companies, ... Generic dru...
Regulatory in Biological News

Food counterfeiting, contamination outpace international regulatory systems

CHICAGO Intentionally contaminated Chinese milk killed several children and sickened 300,000 more, causing concern around an increasingly connected world economy. Demand for inexpensive products virtually guarantees future repeats of food adulteration and counterfeiting from overseas, Michigan St...

New data suggest 'jumping genes' play a significant role in gene regulatory networks

CHICAGO, IL--Research performed in the Center for Biomolecular Science & Engineering (CBSE) at the University of California, Santa Cruz, suggests that mobile repetitive elements--also known as transposons or "jumping genes"--do indeed affect the evolution of gene regulatory networks. David Haus...

Caltech researchers help unlock the secrets of gene regulatory networks

PASADENA, Calif.-- A quartet of studies by researchers at the California Institute of Technology (Caltech) highlight a special feature on gene regulatory networks recently published in the Proceedings of the National Academy of Sciences ( PNAS ). The collection of papers, "Gene Networks in De...

New regulatory mechanism discovered for cell identify and behavior in forming organs

CINCINNATI Two proteins interact in a previously unknown molecular mechanism that may have broad implications in future studies looking for the causes of defective organs in fetuses, metastatic cancers and other diseases, according to researchers at Cincinnati Children's Hospital Medical Center. ...

Use of nanomaterials in food packaging poses regulatory challenges

Washington, DC Engineered nanoscale materials (ENMs), which contain novel properties that offer potential benefits for use in food packaging, raise new safety evaluation challenges for regulators and industry, according to a report released today by the Project on Emerging Nanotechnologies (PEN) ...

Type 1 diabetes triggered by 'lazy' regulatory T-cells: McGill researchers

This release is also available in French . A research team led by Dr. Ciriaco A. Piccirillo of McGill Universitys Department of Microbiology and Immunology has discovered that in some individuals, the specialized immunoregulatory T-cells that regulate the bodys autoimmune reactions may los...

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Regulatory in Biological Technology

Dow AgroSciences, Monsanto Complete U.S. and Canadian Regulatory Authorizations for SmartStax Corn; Plans Set to Launch Seed Platform on 3 Million- to 4 Million-Plus Acres

INDIANAPOLIS and ST. LOUIS, July 20 /PRNewswire-FirstCall/ -- U.S. and Canadian farmers are one step closer to realizing the greater whole farm corn yield advantages of a new corn seed trait combination that will provide the most comprehensive insect and weed control and allow farme...

PharmAthene's 2nd Generation rPA Anthrax Vaccine, SparVax(TM), Completes FDA Regulatory Strategy Review

ANNAPOLIS, Md., July 9 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE Amex: PIP ), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's propos...

Johnson & Johnson Announces Regulatory Clearance for Its Planned Acquisition of Cougar Biotechnology

NEW BRUNSWICK, N.J., June 17 /PRNewswire-FirstCall/ -- Johnson & Johnson (NYSE: JNJ ) today announced the U.S. Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act with respect to its previously announced planned ...

NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)

20-Patient Study to Evaluate FDA-Approved Topical Anesthetic Pretreatment SAN MATEO, Calif., June 10 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX ) announced today that the U.S. Food and Drug Administration (FDA) agreed to its proposed study to evaluate Qutenza(TM) in patients w...

SyntheMed Receives Australian Regulatory Approval for REPEL-CV(R)

ISELIN, N.J., May 28 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, announced today that REPEL-CV, the company's bioresorbable adhesion barrier film for the reduction of adhesi...

Agendia Supports Genentech's Citizen's Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards

HUNTINGTON BEACH, California, and AMSTERDAM, May 28 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, today announced its strong support of Genentech's Citizen's Petition. Filed on December 5, 2008, Docket No. FDA-2008-P-0638-0001/CP petitions that all in vitro diagnosti...
Regulatory in Biological Products

Human Regulatory T cell (Foxp3 / CD4 / CD25) Flow Cytometry staining Kit from eBioscience

Description: Human Regulatory T cell Staining Kit #2 (w/ APC Foxp3 PCH101, FITC CD4, PE CD25)...
Company:eBioscience

Rabbit Anti-Human Protein Kinase-A (PKA) Regulatory subunit IIB Antibody, Unconjugated from CEDARLANE Laboratories Limited

Description: Anti-Protein Kinase-A (PKA) Regulatory subunit IIB; rabbit host...
Company:CEDARLANE Laboratories Limited

APAgene Genome Walking Kit from Bio S&T

Description:...ary ingredients are provided in each kit. The Genome Walking Kit can be used for gap filling, localized cloning of genomic DNA, isolating promoter and regulatory sequences corresponding to cloned cDNAs, 5 and 3 RACE of first-strand cDNAs, identifying intron/exon junctions....
Company:Bio S&T

pHyPer-dMito from Evrogen JSC

Description:...intracellular hydrogen peroxide (H2O2), one of the main ROS generated by cells. Developed on the basis of yellow fluorescent protein inserted into the regulatory domain of Escherichia coli protein OxyR (OxyR-RD), HyPer demonstrates submicromolar affinity to H2O2 and at the same time is insensitive to other oxid...
Company:Evrogen JSC

GeneSwitch-CHO Cell Line from Invitrogen

Description:... The GeneSwitch Cell Lines stably express the regulatory GeneSwitch protein from pSwitch. Each cell line is functionally tested for induction ability by transient transfection with the expression control vec...
Company:Invitrogen

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

Description:...e 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 have...
Company:GeneTex
Regulatory in Biological Definition

Allostery

...c inhibition occurs when the binding of one ligand decreases the affinity for substrate at other active sites. For example, when 2,3-BPG binds to a regulatory site on hemoglobin, the affinity for oxygen of all subunits decreases or increases. Related topics cooperative binding enzyme kineti...

Allostery

...c inhibition occurs when the binding of one ligand decreases the affinity for substrate at other active sites. For example, when 2,3-BPG binds to a regulatory site on hemoglobin, the affinity for oxygen of all subunits decreases or increases. Related topics cooperative binding enzyme kineti...

Amino acid

...onditions protonation of the nitrogen occurs, changing the properties of histidine and the polypeptide as a whole. It is used by many proteins as a regulatory mechanism, changing the conformation and behavior of the polypeptide in acidic regions such as the late endosome or lysosome . I Ile ...

Apoptosis

...s and then continue with a necrosis. Readers should be aware, however, that the apoptotic pathways that have been summarily described are subject to regulatory mechanisms, and that there is not a 1-to-1 relationship between the reception of TNF or FasL and the complete execution of an apoptotic pathway. Fas, ...

Bioinformatics

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

Cell growth

...ll division before reaching the normal size ( wee mutants). The Wee1 protein is a tyrosine kinase . It normally phosphorylates the Cdc2 cell cycle regulatory protein on a tyrosine residue. This covalent modification of the molecular structure of Cdc2 inhibits the enzymatic activity of Cdc2 and prevents...
Regulatory in Biological Dictionary

UvrA

...evised and agreed upon by all UVRA Town Directors. ... uvrA . Information for uvrA , and also upstream and downstream flanking ... Reported regulatory sites for uvrA : Genome coordinates. Source. Transcription factor ... Furthermore, the TFO was dissociated from its duplex binding site by UvrA...

Untranslated RNA

...e... DsrA is a small untranslated RNA that regulates expression of two global ... The untranslated RNA DsrA regulates at least two global regulatory networks by ... An RNA domain within the 5' untranslated region of the tomato bushy stunt virus ... of the 5' untranslated region (UTR) i...

Ubiquitin

... Ubiquitin is a small, highly-conserved regulatory protein that is ubiquitously expressed in eukaryotes. Ubiquitination refe...tin , a highly conserved small protein. Ubiquitin -mediated degradation of regulatory proteins plays important roles in ... Pfam is a large collection of p...

Structural gene

...gene is a gene that codes for any RNA or protein product other than a regulatory factor . It may code for a structural protein, an enzyme, or an RNA mo...ce in living organisms. ... The structural genes and the respective regulatory sequences (promoters and terminators) which have been used as transgenes ar...

Stringency

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

Repressor

...hemistry), ...gene in a functional unit called an operon. Ultimately, the activity of the operon is ... Genetics: repressor gene (encodes for regulatory protein) ... Gilbert, Walter: isolation of repressor molecule ... Repressor - Wikipedia, the free encyclopedia ... Pronunciation of represso...
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