Posts tagged fda

• Shelhigh: Anatomy of an FDA Medical Device Products Seizure

  Armand Rossetti | December 03, 2008 8:18 PM | 0 CommentsWest Palm Beach, FL Category: Medical Devices & Implants
  

  Usually, our discussions address how the FDA might have timely recalled defective and dangerous medical devices and drugs. However, this is a story about the way that the FDA seems to have...

• Circulating Levaquin leaves the bloodstream, deposits in Achilles’ tendons, and alters tendon cells

  Armand Rossetti | December 02, 2008 10:42 AM | 0 CommentsWest Palm Beach, FL Category: Defective & Dangerous Products
  

  Both short and long term treatment with fluoroquinolone antibiotics may cause tendon matrix alteration that can lead to tendinopathy with subsequent rupture. Tendinopathy is newer all-inclusive...

• Ortho Evra Birth Control Patch Costing Consumers And J&J

  Eddie Farah | November 26, 2008 9:59 PM | 0 CommentsJacksonville, FL Category: FDA & Prescription Drugs
  

  It’s hard to believe it is still on the market. Johnson & Johnson has paid about $69 million to settle hundreds of lawsuits by women who used the Ortho Evra birth-control patch. Unlike...

• CEO Don Earhart updates Wall Street about I-Flow’s On-Q Pain Pump chondrolysis lawsuits

  Armand Rossetti | November 21, 2008 4:13 PM | 0 CommentsWest Palm Beach, FL Category: Defective & Dangerous Products
  

  On October 12, 2007, Biomedical Innovation headlined, “I-Flow faces lawsuits, defends its pain pump.” In that story, Orlando Rodriguez, vice President of marketing at I-Flow indicated...

• Chantix: Why the Rush?

  Armand Rossetti | November 16, 2008 3:43 PM | 2 CommentsWest Palm Beach, FL Category: Defective & Dangerous Products
  

  In May 2006, the Food and Drug Administration (FDA) approved Pfizer’s Chantix (varenicline tartrate), a smoking cessation drug. Reportedly under priority review, the FDA had cut the usual...

• Connecting the dots: Reasons why fluoroquinolones such as Levaquin destroy connective tissue matrices found in tendons all over the body

  Armand Rossetti | November 14, 2008 2:30 PM | 0 CommentsWest Palm Beach, FL Category: Defective & Dangerous Products
  

  Sometimes searching for information has to occur outside the box. For example, who would have thought that a scholarly paper about eye drops would contain information central to understanding how...

• The FDA Reports No Association between Bisphosphonate Use and Atrial Fibrillation

  Armand Rossetti | November 13, 2008 9:54 AM | 0 CommentsWest Palm Beach, FL Category: FDA & Prescription Drugs
  

  Yesterday, the FDA released an update about the agency’s safety data review, regarding the increased risk of atrial fibrillation in patients treated with seven available bisphosphonate...

• Regranex Gel (becaplermin): Is It Too Risky to Use?

  Armand Rossetti | November 11, 2008 1:25 PM | 0 CommentsWest Palm Beach, FL Category: Defective & Dangerous Products
  

  Regranex is a prescription gel that diabetic patients apply directly to foot and leg ulcers. On June 6, 2008, The Food and Drug Administration (FDA) posted a follow up communication about their...

• Is Intellectual Property Management a Missing Piece of the FDA’s Regulatory Puzzle?

  Armand Rossetti | November 05, 2008 11:04 AM | 3 CommentsWest Palm Beach, FL Category: Defective & Dangerous Products
  

  Should the FDA establish an Intellectual Property Committee (IPC) to oversee licensing and distribution of pharmaceutical and medical device intellectual property? The following discussion...

• Byetta: A Story About FDA Approval, FDA Warnings, and Amylin & Lilly’s Quest to Build Shareholder Value; What about Preemption versus Patient Safety?

  Armand Rossetti | November 02, 2008 3:38 PM | 0 CommentsWest Palm Beach, FL Category: FDA & Prescription Drugs
  

  Byetta (exenatide) is an analogue of glucagon-like peptide (GLP-1) derived from the saliva of a Gila monster. Injected twice daily an hour before meals, the drug mimics GLP-1 and enhances insulin...