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Page 35 of 44 Pages |
Storm of Regulatory, Legal Challenges Makes Boston Scientific an ‘Above Average’ Risk
FDAnews
- Sunday, August 13, 2006
Saddled with mounting recalls, regulatory actions and lawsuitsrelated mostly to its recent acquisition of Guidant, Boston Scientific is an increasingly risky proposition for investors, a market analyst
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Industry Promotes Cost Savings of Devices, Diagnostics
FDAnews
- Sunday, August 13, 2006
Lawmakers and government regulators need to consider the cost savings that devices and diagnostics offer to the U.S. healthcare system when making decisions that could affect patients’ access to new treatments, say industry leaders and at least one Senate
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ppeals Court Calls State DME Medicaid Policy ‘Unreasonable’
FDAnews
- Sunday, August 13, 2006
A panel of the Eighth U.S. Circuit Court of Appeals June 22 overturned a ruling in a case where a Missouri policy denied Medicaid device coverage to most of the state’s adult program
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Debate Continues in Massachusetts Over Reprocessed Devices
FDAnews
- Sunday, August 13, 2006
A bill under consideration in the Massachusetts state legislature offers patients the option of giving their informed consent before being treated with reused, or “reprocessed,” devices designed for single use
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Device Industry Fully Engaged in U.S.-Korea Free Trade Negotiations
FDAnews
- Sunday, August 13, 2006
An initial round of trade negotiations between the U.S. and South Korea in early June has “significant implications” for the device and diagnostics industry, AdvaMed said June
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German-Based EKSA Cited for QS, MDR Violations
FDAnews
- Sunday, August 13, 2006
ESKA Implants was issued a May 16 warning letter for quality system (QS) and medical device reporting deficiencies that were uncovered during a November 2005 inspection of the company’s Lubeck, Germany,
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CDRH Drop in Warning Letters Cited As Lawmakers Blast FDA
FDAnews
- Sunday, August 13, 2006
The FDA center responsible for monitoring devices and diagnostics may be slacking on enforcing agency regulations, a House lawmaker
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Briefs
FDAnews
- Sunday, August 13, 2006
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ditor's Note:
FDAnews
- Sunday, August 13, 2006
In observance of the Independence Day holiday, FDAnews Device Daily Bulletin will not be published Tuesday, July 4. The next issue will be published Wednesday, July
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MOUNTING COSTS OF FALSE CLAIMS A WAKE-UP CALL FOR INDUSTRY
FDAnews
- Sunday, August 13, 2006
Government enforcement agencies are increasing their scrutiny of deceptive advertising practices in the marketing divisions of device and diagnostics firms, an FTC official said June
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J&J ACQUIRES PFIZER CONSUMER HEALTHCARE DIVISION
FDAnews
- Sunday, August 13, 2006
Johnson & Johnson (J&J) is acquiring Pfizer's consumer healthcare division for $16.6
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FDA PUBLISHES INFORMATION ON RECENTLY APPROVED FACIAL IMPLANTS
FDAnews
- Sunday, August 13, 2006
The FDA has issued updated information Juvederm 24HV, Juvederm 30 and Juvederm 30HV gel implants, which were approved on June
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MITH & NEPHEW GETS SUBPOENAED BY JUSTICE DEPT.
FDAnews
- Sunday, August 13, 2006
Smith & Nephew became the latest orthopedic-products maker on Friday to get a subpoena from the U.S. Department of Justice as an examination over potential violations of antitrust law
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NTEGRA LIFESCIENCES ANNOUNCES AGREEMENT TO ACQUIRE KINETIKOS MEDICAL, INC.
FDAnews
- Sunday, August 13, 2006
Integra LifeSciences Holdings Corporation announced today that it has agreed to acquire the shares of Kinetikos Medical, Inc. ("KMI") for approximately $40 million in cash, subject to certain adjustments, including future payments based on the performance of the KMI business after the
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BAYER SELLS DIAGNOSTIC BUSINESS TO SIEMENS
FDAnews
- Sunday, August 13, 2006
Bayer Diagnostics India Ltd will become a part of the Siemens Group, following the worldwide sale of the Bayer Group's diagnostic business to Simens AG for a price of 4.2 billion
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INSITE VISION SUBMITS NDA FOR AZASITE IN THE TREATMENT OF BACTERIAL CONJUNCTIVITIS WITH U.S. FDA
FDAnews
- Sunday, August 13, 2006
Thursday, InSite Vision, Inc., an ophthalmic products company, revealed the submission of a New Drug Application or NDA with the U.S. Food and Drug Administration for AzaSite indicated in the treatment of bacterial
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NOVEN CONFIRMS AVAILABILITY OF DAYTRANA METHYLPHENIDATE TRANSDERMAL SYSTEM
FDAnews
- Sunday, August 13, 2006
Noven Pharmaceuticals, Inc. today confirmed that Shire plc has launched Daytrana (methylphenidate transdermal system), the first and only transdermal medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six to twelve years, and that the product is now available in retail
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CYTOGENIX RECEIVES THE 2006 FROST & SULLIVAN TECHNOLOGY INNOVATION AWARD FOR SYNDNA
FDAnews
- Sunday, August 13, 2006
Frost & Sullivan, the leading global growth consulting company has chosen CytoGenix as the recipient of the 2006 Technology Innovation Award in biotechnology processing for the development of the synDNA large-scale DNA production
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BAXTER HEALTHCARE SIGNS CONSENT DECREE FOR CGMP VIOLATIONS IN MAKING INFUSION PUMPS
FDAnews
- Sunday, August 13, 2006
Baxter Healthcare has signed a consent decree with the FDA related to violations of current good manufacturing practices (cGMPs) in making two brands of infusion pumps, the agency said June
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HOUSE BILL PROPOSES MORATORIUM ON PAYMENT CUTS FOR MEDICARE DIAGNOSTIC SERVICES
FDAnews
- Sunday, August 13, 2006
A House bill would place a two-year moratorium on Medicare payment cuts for diagnostic imaging that were included in the 2005 Deficit Reduction Act (DRA) passed by Congress in
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