Abbott Receives FDA CLIA Waiver for Use of Five Additional Cartridges on the i-STAT Handheld Blood Analyzer

PRINCETON, N.J., Jan. 19 /PRNewswire-FirstCall/ -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for five additional test cartridges used by its i-STAT handheld blood analy...

HHS Approves Medicaid Waiver to Create New Indiana Health Plan for Uninsured Hoosiers

Healthy Indiana Plan Combines Personal Responsibility and Public Dollars WASHINGTON, Dec. 14 /PRNewswire-USNewswire/ -- HHS Secretary Mike Leavitt today announced the approval of a Medicaid waiver that will allow the state of Indiana to implement an innovative health care proposal giving a...

StatSure's Patented HIV 'Barrel' Technology Receives CLIA Waiver From FDA

FRAMINGHAM, Mass., Nov. 5 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR.OB) announced today that the U.S. Food and Drug Administration ("FDA"), through its Center for Devices and Radiological Health, has approved a waiver under the Clinical Laboratory Im...

Rural/Metro Enters Into Amendment and Waiver to Its Senior Credit Facility; Provides Restatement Details

SCOTTSDALE, Ariz., Oct. 17 /PRNewswire-FirstCall/ -- Rural/Metro Corporation (Nasdaq: RURL ) announced today that it has entered into an amendment and waiver to its senior secured credit facility effective September 1, 2007. The amendment and waiver were required as a result of the Company's...

Abbott Broadens Use of i-STAT Handheld Blood Analyzer with CLIA Waiver Granted by FDA for CHEM8+ Test Cartridge

EAST WINDSOR, N.J., Oct. 2 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT ) announced today that the U.S. Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendements of 1988 (CLIA) for its handheld i-STAT CHEM8+ test cartridge, making it mor...

Center for Consumer Freedom Releases 'Don't Sue Me Santa' Christmas Cookie Liability Waiver

WASHINGTON, Dec. 20 /PRNewswire-USNewswire/ -- The following is being issued by Center for Consumer Freedom: With Christmas quickly approaching, millions of Americans are preparing to celebrate time-honored traditions like caroling, tree-trimming, and leaving cookies and milk out for Santa...

Students wants to extent Tution waiver in Ontario

Ontario College and University will be stopping the Tution waiver which they were giving to their school students for the past two years. The Minister Chris Bentley announced that from next year the students have to pay their tution fees and he said that// the quality of education would be increase...

Immigration Attorneys Make Immigration Law & Employment Visas Easier for Foreign Workers, U.S. Employers, Corporations and Corporate Counsel

... Overview of Immigration Laws Visas and Visa Choice Criteria Current Immigration Trends F Visa H-3 Visa (H3) J-1 Visa (J1) Visa waiver and B-1 Visas (B1) H-1B Visa (H1B) L-1 Visa (L1) NAFTA: B-1 and TN Other Visas (E, O, P) Employment Based Immigration Categories ...

Pederson Immigration Law Group Attorneys Featured in 14th Annual J-1/H-1B Foreign Physician Immigration Conference and Job Fair Series

... on October 24. Each conference will present seminars on topics such as finding and keeping a J-1waiver job, avoiding the H-1B cap and navigating J-1 waiver and permanent residence options. The series will also include job fairs hosted by employment recruiters to facilitate job opportunities for medical R...

Doctor Mortgage Alliance, The National Real Estate Referral Firm That Specializes In Finding Real Estate Loans, Has Just Expanded Their Services

...te market and provide an extra incentive to what typically is referred to as a "first-time homebuyer". The extra incentive available is the waiver of what is known as Mortgage Insurance along with many flexible qualifying standards and little down payment. Having No Mortgage Insurance can save t...

waiver in Medical Technology

CLIA Waiver Submitted for Rapid HIV Test Employs StatSure's 'Barrel' Technology

FRAMINGHAM, Mass., Aug. 14 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR - News) is pleased to announce that its patented, "barrel- test" format for the detection of antibodies to HIV-1/2 in human whole blood, serum, and plasma has completed the trials n...

Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders

...drug developer with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance, waiver of Prescription Drug User Fee Act (PDUFA) filing fees, and a seven-year period of U.S. marketing exclusivity if the drug is the first of its type appr...

Enobia Pharma Receives FDA Orphan Drug Designation for Hypophosphatasia Product Candidate ENB-0040

...ity to apply for funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential waiver of the FDA's application user fee. About Hypophosphatasia Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease. Patie...

Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351

...iseases that affect fewer than 200,000 people in the United States and provides the benefits of market exclusivity for seven years, tax credits, and a waiver of FDA user fees. "The decision by FDA to grant CPX-351 orphan drug designation reinforces the importance of developing novel products for the treat...

U.S. Navy Submits Protocol for Field Trauma Trial of Hemopure(R)

...changes intended to address FDA comments. The newly filed protocol, by incorporating informed consent, is intended to remove requirements attendant to waiver of informed consent. To date, Congress has appropriated a total of $24.2 million for the development of Hemopure. Biopure Corporation Biopure Corp...

Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance

...ely complex laboratories now may use the HemoCue WBC Analyzer to quickly produce results during a single office visit. HemoCue plans to apply for CLIA waiver for the HemoCue WBC Analyzer shortly, which if granted, would permit physicians to offer the test in CLIA-waived laboratories, which are far more prev...

StatSure Signs Strategic Financing and License Deals with Inverness Medical Innovations

...his license pertains to HIV tests using formats other than the StatSure's "barrel format" which is already being sold by Inverness and awaiting a CLIA waiver from the FDA. The strategic investment consists of a purchase of 1,428,572 common shares at a price of 35 cents per share. Additionally, Inverness re...

Immtech Announces Interim Analysis in Phase III African Sleeping Sickness Trial

...nted to pafuramidine's African sleeping sickness indication Fast Track and Orphan Drug status, which is expected to accelerate review and provides for waiver of the Prescription Drug Users Fee. The interim analysis was specified in the clinical trial protocol to evaluate the efficacy of pafuramidine compar...

US FDA Grants Orphan Drug Status to Immtech's Pafuramidine for Treatment of African Sleeping Sickness

...Immtech with numerous financial and regulatory benefits during pafuramidine's development, including government grants for conducting clinical trials, waiver of New Drug Application submission fees, tax credits, and a seven-year market exclusivity upon final FDA approval. Pafuramidine is currently in phase...

waiver in Medical Dictionary

Immunization

...service delivery and accelerated disease control. Vaccine research and development ... Download Immunization Form and Policy. Download Vaccine waiver for Religious Exemption ... FIU IMMUNIZATION POLICY ... NEED AN IMMUNIZATION DOCUMENTATION FORM? ... Website for the Immunizations Branch at...

waiver in Biological News

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

... 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 access control ...

Pfizer supports open access publishing for researchers in low-income countries

... Pfizer announced an agreement with BioMed Central to launch an open access waiver fund which will support automatic waivers of publication fees for authors from low-income countries. Thanks to the open access waiver fund, researchers in low-income countries can publish research articles in ...

2008 Ocean Sciences Meeting -- media advisory 2

...nor a permanent resident of the United States, you need a visa to cover meetings in the U.S. This applies also to reporters from countries in the Visa waiver Program, who do not need visas to visit the U.S. as tourists. For current information, see the official State Department web site: http://travel.stat...

Media advisory -- 2008 Ocean Sciences Meeting

...nor a permanent resident of the United States, you need a visa to cover meetings in the U.S. This applies also to reporters from countries in the Visa waiver Program, who do not need visas to visit the U.S. as tourists. For current information, see the official State Department web site: http://travel.stat...

First-ever study to link increased mortality specifically to carbon dioxide emissions

...the Environmental Protection Agency denied California and 16 other states a waiver that would have allowed the states to set their own emission standards for carbon dioxide, which are not currently regulated. The EPA denied the waiver partly on the grounds that no special circumstances existed to warrant an e...

waiver in Biological Technology

GlaxoSmithKline Announces Waiver of a Condition to the Tender Offer for Genelabs Technologies, Inc.

LONDON and PHILADELPHIA, Dec. 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline (LSE/NYSE: GSK ) announced today that it is waiving a condition relating to a pending lawsuit in the previously announced tender offer to purchase all of the outstanding shares of common stock of Genelabs Technologies, Inc...

HemoCue Receives First FDA CLIA Waiver in Diagnostics Industry for Quantitative Point-of-Care Test for Microalbuminuria, a Kidney and Cardiovascular Disease Risk Marker

MADISON, N.J., June 18 /PRNewswire-FirstCall/ -- HemoCue(R) AB, a global point-of-care diagnostic test manufacturer and wholly owned subsidiary of Quest Diagnostics Incorporated (NYSE: DGX ), today announced that its HemoCue Albumin 201 System is the first quantitative point-of-care test for ...

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

...2009, as well as certain other of the Company's SEC filings, could have a material impact on the Company's financial results; (19) the satisfaction or waiver of the other closing conditions in the previously disclosed Gestiva(TM) acquisition agreement; (20) the possibility that the auction rate securities h...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

...ons DOR to be able to take advantage of a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application for orBec((R)), and certain tax credits. orBec((R) )is a high...

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

...continue to follow current exit procedures, which require travelers to return their paper Form I-94 (Arrival-Departure Record) or Form I-94W (for Visa waiver Program travelers) to an airline or ship representative. Since 2004, the U.S. Department of State (DOS) and U.S. Customs and Border Protection (...

Amylin Pharmaceuticals Provides Shareholders with Update Regarding Recent Developments

...e debt acceleration provision in our senior credit agreement. We have contacted the administrative agent for that facility to request an amendment or waiver of that provision, which would be automatically triggered by a change in a majority of the Board regardless of whether or not the existing Board appro...

PharmaNet Development Group Gives Notice of Anticipated Fundamental Change and Merger to Holders of Its Convertible Notes

... as March 20, 2009, subject to the satisfaction or waiver of a number of conditions (the "Anticipated Effect...ion of the Offer is subject to the satisfaction or waiver of a number of conditions set forth in the Merger ...on of the Offer and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreemen...

KV Pharmaceutical Enters Into Consent Decree With FDA

...2009, as well as certain other of the Company's SEC filings, could have a material impact on the Company's financial results; (17) the satisfaction or waiver of the other closing conditions in the previously disclosed Gestiva(TM) acquisition agreement; (18) the possibility that the auction rate securities h...

Gerson Lehrman Group and BIO Collaborate to Identify Scientific Expertise for the Seventh Annual BIO Investor Forum

...ks of Gerson Lehrman Group [in the United States and other countries]. Failure to list any other Gerson Lehrman Group trademarks does not constitute a waiver of any rights to any Gerson Lehrman Group trademarks, including unregistered trademarks. Other names included in this press release may also be the re...

SGX - Lilly Merger Offer Receives Positive Opinions From Proxy Advisory Firms

...6 applicable to the proposed merger expired on August 11, 2008. The completion of the proposed merger continues to be subject to the satisfaction or waiver of a number of closing conditions, including, among others, (1) adoption of the agreement and plan of merger ("Merger Agreement") by the holders of a ...