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LegalView Reveals Details of the FDA Mandated Black Box Warning For Fluoroquinolone Antibiotics Such as Cipro and Levaquin

LegalView reported of a recent FDA warning for antibiotics under the fluoroquinolones drug family that will now require a black box warning, the strongest warning issued by the FDA. The FDA instituted the mandate due to the greater risk of tendonitis and tendon rupture among patients prescribed t...

Breast cancer survivors slacken on mandated annual mammograms

According to a new study, breast cancer survivors who are at a high risk of a relapse or cancer of the other breast should ideally be getting an annual screening// or mammogram done. But the study has found a decline in the annual follow-up trend especially during the five year period after the can...

Many Texas Docs Not Pushing HPV Vaccine for Girls

...said they always recommend HPV vaccine to girls, 68.4 percent said they were likely to recommend the vaccine to boys, and 41.7 percent agreed with the mandated vaccination, the researchers found. Doctors in academic practices were more than twice as likely to recommend the vaccine as those in non-academic ...

BD Adds Surveillance Capability to Infectious Disease Portfolio

...are-associated infections (HAIs). AICE software tracks emerging drug-resistant organisms and the incidence of HAIs. It also supports compliance with mandated infection reporting requirements by the U.S. Centers for Disease Control and Prevention, as well as participation in the National Healthcare Safety Ne...

Data Conversion Laboratory Supports Newest SPL Requirements For Life Sciences Industry

...used by the FDA community to facilitate communicating drug labeling data reliably among various medical groups. Since 2005, the FDA CDER division has mandated that all human prescription drugs be provided in SPL. Beginning in June, 2009 the FDA has required SPL filings for biologics, veterinary medicines an...

CorVel Announces Revenues and Earnings

...lly launched clearinghouse services in Minnesota in response to the State's mandated electronic billing and connectivity between all group purchasers and health...and is expanding that service offering to include communications soon to be mandated under the legislation covering Centers for Medicare/Medicaid Services (CMS)...

Antidepressant Use in U.S. Has Almost Doubled

...tor of the Center for the Study of Prevention of Suicide at the University of Rochester Medical Center. This happened despite a "black box" warning mandated for many antidepressant medications by the U.S. Food and Drug Administration in 2004, the study authors noted. Lower rates of increases in antidepr...

AMERIGROUP Reports Q2 Net Income of $49.6 Million or $0.94 per Diluted Share, Including $0.43 per Diluted Share Positive Impact from Tax Adjustment

...changes; increased use of services, increased cost of individual services, epidemics, the introduction of new or costly treatments and technology, new mandated benefits, insured population characteristics and seasonal changes in the level of healthcare use; our ability to enter into new markets or remain in e...

Allsup Answers Common Questions People Have About Social Security Disability

...one can find out if they are eligible and likely to qualify for SSDI benefits before they even submit their application." SSDI is a federally mandated insurance program overseen by the Social Security Administration (SSA) that operates separately from the retirement and SSI programs. SSDI provides m...

American Association for Homecare Supports Crackdown on Medicare Scammers in Houston, Boston, New York, Louisiana

...ly or before it starts. Among the provisions detailed in the legislative proposal are more rigorous quality standards, increased penalties for fraud, mandated site inspections for new providers, and real-time claims analysis. On May 6, 2009, Sen. Martinez introduced Seniors and Taxpayers Obligation ...
mandated in Medical Technology

New AHRQ Study Finds Mixed Evidence on Use of Radiofrequency Catheter Ablation for Treating Atrial Fibrillation

...uency catheter ablation. As a condition of catheter approvals, the FDA mandated that the catheters' manufacturer must conduct two post approval studies (PAS) to collect long term safety data. The mandated studies apply only to FDA-approved catheters, and not to devices used off-l...

Edifecs, CAQH and Harvard Pilgrim Health Care Will Examine CORE Phase II Testing Outcomes and Lessons Learned at HIMSS09 Interoperability Showcase

...tification testing including elements of the newly mandated 5010 Rules, in a presentation at the HIMSS09 Inter...e II rules, is already realizing benefits from now mandated 5010 standards by using the CORE operating rules. ...il 2006 - well ahead of the recommendations in the mandated 5010. The CORE rules, using standards, specify the...

Schering-Plough Announces Results of the Early ACS Trial

...n enrollment, followed by greater than or equal to 75 mg daily thereafter. Thienopyridine was substituted in aspirin-intolerant patients. The protocol mandated either weight-based unfractionated heparin or weight- and renal-adjusted enoxaparin by investigator choice. After a study amendment, bivalirudin and f...

Taxus Atlas Studies Reinforce Safety and Efficacy of Boston Scientific's Next-Generation Taxus Liberte Stent

...iberte Stent using balloon pre-dilatation. The control arm for the trial is the angiographic cohort of the TAXUS ATLAS Workhorse clinical trial, which mandated pre-dilatation. Although the ATLAS Workhorse and ATLAS Direct Stent trials had the same inclusion and exclusion criteria, simpler lesions were selecte...

Task Force Recommends Screening for Hearing Loss in All Newborns

...are 3 months old. Thirty-nine U.S. states have enacted legislation related to universal newborn hearing screening. Laws differ on whether screening is mandated or encouraged, how results are reported and how screening is funded. "Screening for hearing loss should be part of every newborn infant's health car...

Presentation of Data on Progen's Cancer Epigenetic Targets Platform

...ies, including without limitation, risks associated with drug development and manufacture, risks inherent in the extensive regulatory approval process mandated by the United States Food and Drug Administration and the Australian Therapeutic Goods Administration, delays in obtaining the necessary approvals for...

Node-Negative Early Stage Breast Cancer Patients Benefit from Taxotere(R)-Based Chemotherapy

...ts with tumors > 5 cm; tamoxifen was given for 5 years to all patients with endocrine responsive tumors. A study amendment initiated during enrollment mandated the use of G-CSF with the first cycle of TAC, in order to reduce the incidence and severity of hematological toxicities and febrile neutropenia. The...

Progen Resumes Phase 1 Development of Anti-Cancer Agent, PG-11047

...ies, including without limitation, risks associated with drug development and manufacture, risks inherent in the extensive regulatory approval process mandated by the United States Food and Drug Administration and the Australian Therapeutic Goods Administration, delays in obtaining the necessary approvals for...

PG500 Series Presented at the AACR Annual Meeting in San Diego

...ies, including without limitation, risks associated with drug development and manufacture, risks inherent in the extensive regulatory approval process mandated by the United States Food and Drug Administration and the Australian Therapeutic Goods Administration, delays in obtaining the necessary approvals for...

Progen Announces Commencement of Global Phase 3 Study for PI-88 in Post- Resection Liver Cancer

...ies, including without limitation, risks associated with drug development and manufacture, risks inherent in the extensive regulatory approval process mandated by the United States Food and Drug Administration and the Australian Therapeutic Goods Administration, delays in obtaining the necessary approvals for...
mandated in Medical Products

PatientSafe® SURGICHIP™

Description:... complete audit trail to the verification process, from patient scheduling right through to the surgical Time Out prior to the start of a procedure as mandated by JCAHO....
Company:AMT Systems

Full Service Clinical Reference Laboratory

Description:...thologist (CAP) accreditation. This award indicates that Enzo has passed an extremely rigorous series of inspections far more sophisticated than those mandated by licensing authorities....
Company:Enzo Clinical Labs, Inc.

QED A150 Saliva Alcohol Test

Description:... The DOT-approved A150 test is used for workplace testing, most publicly for federally mandated testing of transportation workers, but also in private company "drug free workplace" programs. Each hash mark is 0.01% or 10 mg/dL....
Company:STC Technologies Inc.

HARMONY® Cardiology Module

Description:... The HARMONY Cardiology Module incorporates an integrated Medical Records and Transcription capability with Open Systems Technology mandated by the national Health Care HL7 communications protocols. Allowing for easy access to hospital information insurers and physician inter-office communi...
Company:Medical Technology International

HARMONY® Orthopedics

Description:... The HARMONY Orthopedics Module incorporates an integrated Medical Records and Transcription capability with Open Systems Technology mandated by the national Health Care HL7 communications protocols. Allowing for easy access to hospital information insurers and physician inter-office communi...
Company:Medical Technology International
mandated in Medical Dictionary

IRDS

...pedia, computing dictionary. Established as a capacity building NGO in NWFP in May 2000, Institute of Research and Development Studies ( IRDS ) is mandated to strengthen the efforts for ... Read IRD's Refugee Policy Briefs. Program: AVIPA. View Photos. Agriculture Worldwide ... U.S. Embassy in Cambo...

Emergency contraception

...on . Back Up Your Birth Control Campaign ... BACKGROUND: Emergency contraception —a concentrated dose of the hormone found in ... states have mandated emergency contraception –related services for women who have ... International Consortium (ICEC) promotes access to emergency contraception ...
mandated in Biological News

More than half of Texas physicians do not always recommend HPV vaccine to girls

... said they always recommend the HPV vaccine to girls, 68.4 percent said they were likely to recommend the vaccine to boys and 41.7 percent agreed with mandated vaccination. When the researchers assessed the predictors of vaccine recommendation, they found that those in an academic vs. non-academic practic...

Improved air quality during Beijing Olympics could inform pollution-curbing policies

...well as gasoline and diesel fuel engines were required to achieve emissions standards equivalent to European Union regulations. A similar standard was mandated starting in June 2008 for 20,000 buses and 66,000 taxies. The improved fuel quality probably enhanced the performance of engines and catalytic convert...

Frost & Sullivan: North American Government Biometrics Markets Thrive With Active R&D Thrust

...activities and initiatives of the government have enabled the North American government biometrics market to become a high revenue generator. The U.S. mandated Visa Waiver Program (VWP), the border management control programs, the national ID programs, driver's license, and the physical access and logical acc...

Study on keeping nuclear bombs from US ports shows misplaced fear over cargo scanning cost

...u/omg/msom2009/ With continuing concern that Al Qaida or other terrorists will try to smuggle a nuclear weapon into the United States, Congress has mandated that, by 2012, all containers bound for the U.S. be inspected overseas. . The paper argues that a test program, the Secure Freight Initiative (SFI)...

MSU lands $2.1 million grant to take part in national autism study

... Clinical and Translational Science Institute, will collect and create a repository for data from nearly 3,000 families as part of the congressionally mandated Study to Explore Early Development. "Autism is a serious disabling condition that has been estimated to occur in one in 150 children in the United ...

Women faring well in hiring process for science faculty jobs at research universities

...presented among those considered for tenure, but those who are considered receive tenure at the same or higher rates than men. The congressionally mandated report examines how women at research-intensive universities fare compared with men at key transition points in their careers. Two national surveys w...

IPM reduces cockroaches and allergens in schools

...at the one using IPM had much lower concentrations of cockroach allergens and zero cockroaches caught in pre-set traps. "North Carolina schools are mandated to convert to IPM by 2011, so these findings give credibility that IPM has superior and longer-lasting results than pesticide use alone," said Dr. God...

Social separation stops flu spread, but must be started soon

...family members inside the home and reducing contact within the wider community. According to Milne, "While such draconian measures seem unlikely to be mandated given their impact on personal freedom, they appear to have a key role to play in delaying the development of a 'worst case' influenza epidemic. They ...

States expand newborn screening for life-threatening disorders

...f where they are born in the United States, nearly all newborns now receive mandated screening for many life-threatening disorders, a remarkable public health a...nditions. In 2005, the ACMG issued a report recommending that 29 screens be mandated for every newborn. In 2005, the first year that the March of Dimes repor...

Diverse landscapes are better: Policymakers urged to think broadly about biofuel crops

...c research aimed at solving complex problems in converting natural materials to energy. The researchers say achieving the biofuel production levels mandated by Congress will take millions of acres to provide the necessary raw materials and will change agricultural landscapes. Understanding how these landsc...
mandated in Biological Technology

Magellan Diagnostic Businesses to Feature Automated Systems and Diagnostic Tests at Clinical Lab Expo

... poisoning, policy-makers at the federal, state, and local level are taking action to encourage the use of LeadCare II to ensure that children receive mandated testing. In 2009, the National Committee for Quality Assurance (NCQA) added completion of blood-lead testing as one of the Healthcare Effectiveness Da...

USC Hospitals Extend Relationship With Quantros to Manage Compliance and Risk

...ons for the Joint Commission, CMS, STS Cardiovascular Registry, ACC-NCDR CathPCI Registry and the AHA's Get with the Guidelines as well as other state mandated reporting bodies. It delivers a seamless, structured framework for the data needed to address quality concerns and implement corrective action. &q...

Study on keeping nuclear bombs from US ports shows misplaced fear over cargo scanning cost

...u/omg/msom2009/ With continuing concern that Al Qaida or other terrorists will try to smuggle a nuclear weapon into the United States, Congress has mandated that, by 2012, all containers bound for the U.S. be inspected overseas. . The paper argues that a test program, the Secure Freight Initiative (SFI)...

Government Mandates Create Guaranteed Market for Bio-Fuel, Says Frost & Sullivan

... In Malaysia, the government will implement the blending of 5% palm-based methyl ester with fossil diesel beginning February 2010 whereas Thailand has mandated B2 on February 2008 and plans to increase to B5 by 2011 which will require almost 4 million liters/day of bio-diesel. The Indonesian government ...

Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter

...emporary, or retrievable, indications, a physician may later perform a second surgical procedure to remove the Option IVC Filter if necessary or where mandated clinically). "This important FDA clearance of the Option IVC Filter continues Angiotech's mission of offering the most highly innovative technology ...

DHS Begins Test of Biometric Exit Procedures at Two U.S. Airports

...d 79, with some exceptions, when they apply for visas or arrive at U.S. ports of entry. US-VISIT has simultaneously worked to create a congressionally mandated automated biometric exit capability, which these pilots will test. US-VISIT provides biometric identification services to federal, state and loca...

Marriott Resort Magically Turns Brown Grease "Green" With The Cost-Cutting Hydrologix GRS

...es to protect our communities and ecosystems. Everyone benefits." Hotel restaurant grease interceptors and grease traps are county or city mandated receptacles to contain the food waste liquids from kitchen drains, in particular problematic F.O.G. (fats, oils, grease). Although covered and periodi...

VeraSun Energy Selects Valero as Successful Bidder for Seven Facilities

... cash collateral order entered by the bankruptcy court in connection with the Company's chapter 11 cases, including requirements to sell assets within mandated deadlines; the ability of the Company to continue to fund operations based upon future revenues and liquidity constraints set forth in existing debtor...

Helix BioPharma Receives Approval to Initiate Phase II Pharmacokinetic Clinical Study of Topical Interferon Alpha-2b in Patients with Low-Grade Cervical Lesions

...ed Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions. The clinical study was designed, as mandated by regulatory authorities, to gather data on the absorption and elimination profile of Topical Interferon Alpha-2b in patients with low-grade cervical...

Strengthening Forensic Toxicology in the United States: The American Board of Forensic Toxicology Response to the National Academy of Sciences Recommendations

... COLORADO SPRINGS, Colo., Feb. 23 /PRNewswire/ -- The National Academy of Sciences (NAS) congressionally mandated report released on February 18, 2009 finds deficiencies in the nation's forensic science system and calls for major reforms and new research. The rep...
mandated in Biological Products

Agilent MSD Security ChemStation for GC and GC/MS from Agilent Technologies

Description:...cquisition, data processing, quantification, library searching and reporting, addressing all the aspects of data security, integrity, and traceability mandated by FDAs 21 CFR Part 11....
Company:Agilent Technologies
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(Date:7/11/2014)... July 11, 2014 Anterior Cruciate Ligament ... but the type of material used to create a ... the game, say researchers presenting their work today at ... Sports Medicine ( AOSSM ). , “Our ... allografts (tissue harvested from a donor) fail more frequently ...
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(Date:7/11/2014)... Janeiro, Brazil- In the brains of all vertebrates, ... allows an electric or chemical signal to be ... synapses, which are the most abundant type of ... formation is crucial for learning, memory, perception and ... synapses critical for brain function. For instance, ...
(Date:7/10/2014)... 2014  Pomerantz LLP has filed a class ... the "Company")(NYSE-MKT: PVCT) and certain of its officers.  ... Court, Middle District of Tennessee ... class consisting of all persons or entities who ... 17, 2013 and May 22, 2014, both dates ...
(Date:7/10/2014)... -- Unisys Corporation,s (NYSE: UIS ) subsidiary in ... that it has been selected by the Dutch Custodial Institutions ... Provision Biometrics solution for penitentiaries across The Netherlands ... a solution based on its open standards-based LEIDA ... is up to seven years, with the new system expected ...
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