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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third Party Review Program...(3)

December 28, 2010 6:39 am | by U.S. Food & Drug Administration | Comments

Section 210 of the FDAMA established section 523 of the FD&C Act (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s). Participation in this third-party review program by...

HeartWare Files PMA Application for FDA Approval of the HeartWare® Ventricular Assist System for a Bridge-to-Transplant Indication

December 28, 2010 6:38 am | by Bio-Medicine.Org | Comments

FRAMINGHAM, Mass. and SYDNEY, Dec. 28, 2010 /- HeartWare International, Inc. (Nasdaq: HTWR ; ASX: HIN) today announced that it has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge...

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Medco Extends URAC Accreditation to Drug Therapy Management, PBM

December 28, 2010 6:38 am | by Bio-Medicine.Org | Comments

FRANKLIN LAKES, N.J., Dec. 28, 2010 /- Medco Health Solutions, Inc., (NYSE: MHS ) today announced that URAC, one of the nation's leading independent health care quality evaluators, has accredited Medco's Pharmacy Benefit Management and Drug Therapy Management (DTM) programs, recognizing...

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Federal Register: Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or NV Consumer Repre...

December 28, 2010 6:34 am | by U.S. Food & Drug Administration | Comments

The FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing.

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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third Party Review Program...

December 28, 2010 6:31 am | Comments

[Federal Register: December 28, 2010 (Volume 75, Number 248)] [Notices] [Page 81616-81617] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr28de10-116] ----------------------------------------------------------------------- DEPARTMENT O

Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third Party Review Program...(2)

December 28, 2010 6:31 am | by U.S. Food & Drug Administration | Comments

Section 210 of the FDAMA established section 523 of the FD&C Act (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s). Participation in this third-party review program by...

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FDA needs 4 more weeks for to review MannKind drug

December 28, 2010 2:45 am | by The Associated Press | Comments

MannKind Corp. said Tuesday the Food and Drug Administration will take an additional four weeks to review the application for the inhaled insulin Afrezza.The agency had initially expected to make a decision by Wednesday.MannKind had asked for approval of the product in March 2009, but the...

Winner Medical and Cotton Inc. Promote PurCotton(R) Brand and Natural(TM) Trademark in Shanghai

December 28, 2010 1:31 am | by Bio-Medicine.Org | Comments

SHENZHEN, China, Dec. 28, 2010 /PRNewswire-Asia/ -- Winner Medical Group Inc. (Nasdaq: WWIN ), ("Winner Medical") a leading manufacturer of medical dressings, medical disposables and non-woven fabric made from 100% natural PurCotton® products in China, today reported that a...

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Sun Healthcare Group, Inc. to Present at the 29th Annual J.P. Morgan Healthcare Conference

December 27, 2010 11:45 am | by The Associated Press | Comments

Sun Healthcare Group, Inc. (NASDAQ: SUNH) today announced that William A. Mathies, the company's chairman and chief executive officer, and L. Bryan Shaul, the company's chief financial officer, will present at the 29th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 10, 2011, at...

Functional Technologies Corporation Retains Pathfinder Ventures Corporation to Provide Investor Relations Services

December 27, 2010 9:45 am | by The Associated Press | Comments

http://www.functionaltechcorp.com () —Functional Technologies Corporation (TSX VENTURE: FEB) is pleased to announce that it has retained the services of Pathfinder Ventures Corporation ("Pathfinder"), of Vancouver, BC, to provide investor relations services, subject to regulatory approval....

ACT collaborates on stem cell bank

December 27, 2010 9:36 am | by Mass High Tech: The Journal of New England Technology | Comments

Advanced Cell Technology Inc. has signed an agreement with Scotland-based Roslin Cells Ltd. to create a human embryonic stem cell (hESC) bank that the company said will meet the development and storage standards of the U.S. Food and Drug Administration and the European Medicines Agency.

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K-V Pharmaceutical Company Announces Filing of Fiscal Year 2010 Annual Report on Form 10-K With the Securities and Exchange Commission(2)

December 27, 2010 9:35 am | by Bio-Medicine.Org | Comments

ST. LOUIS, Dec. 27, 2010 /- K-V Pharmaceutical Company (NYSE: KVa/KVb) today announced the filing of its Form 10-K for its fiscal year ended March 31, 2010 with the Securities and Exchange Commission.  As a result, the Company has met the deadline for filing its delayed fiscal 2010...

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Topical China Industries Research Reports Published at MarketPublishers.com

December 27, 2010 9:34 am | by Bio-Medicine.Org | Comments

LONDON, Dec. 27, 2010 /- Market Publishers Ltd informs that new in-demand ResearchInChina reports on China industries have been added to its catalogue. China Beer Industry Report, 2009-2010 . The report discusses development of China beer industry, provides detailed analysis of key beer...

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Cephalon ends program on Nuvigil as jet lag drug

December 27, 2010 6:45 am | by The Associated Press | Comments

Cephalon Inc. said Monday it will no longer pursue Food and Drug Administration approval of Nuvigil in a new use — as a treatment for jet lag — after new questions from and conversations with the agency.Nuvigil is approved as a treatment for tiredness caused by sleep apnea, narcolepsy, or...

Thermo Fisher completes Lomb Scientific purchase

December 27, 2010 6:45 am | by The Associated Press | Comments

Scientific instrument maker Thermo Fisher Scientific Inc. said Monday that it has completed its previously announced purchase of Lomb Scientific, which makes chemicals, consumables and instruments.Lomb, which has offices in Australia and New Zealand, has about 100 employees and reported about...

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