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• How much stress can a Suzuki GSX-R1000 motorcycle frame take?

  Armand Rossetti | February 12, 2009 4:23 PM | 0 CommentsWest Palm Beach, FL

  In January 2009, Suzuki recalled 26,082 GSX-R1000 (GSX) motorcycles manufactured in 2005 and 2006. Reportedly, the fractures are occurring behind and below the steering neckof the GSX-R1000 K5 or K6...

• What is next with C. R. Bard’s Urethral Bulking agent, Tegress: Is It Too Technique Sensitive and Unpredictable for Continued Effective Use?

  Armand Rossetti | October 30, 2008 5:24 PM | 1 CommentWest Palm Beach, FL

  I have been reporting about problems with tension-free vaginal tape, and approval of vaginal mesh products without tracing the history of submissions to ensure that the initial predicate device was...

• What are the so-called "ancillary ingredients" in AMO's Complete MoisturePLUS?

  Armand Rossetti | June 15, 2007 7:44 PM | 0 CommentsWest Palm Beach, FL

  On April 13, 2005, the FDA approved AMO's Complete MoisturePLUS. This time, AMO represented that Complete MoisturePLUS was the same as the currently marketed solution. But it wasn't just like it,...

• Two Questions that Concern AMO and Acanthamoeba Infections

  Armand Rossetti | June 12, 2007 2:24 PM | 0 CommentsWest Palm Beach, FL

  The cornea is the only tissue in the body that Acanthamoebae (or Acanthamoeba) can invade in individuals with healthy immune systems. Otherwise, those individuals can usually avoid Acanthamoeba infections that affect the skin, brain and lungs. This blog briefly addresses two questions: 1) Why is the cornea more susceptible to Acanthamoeba than other tissues in the body; and 2) How could a...

• The Drug Business, Broadway, and Casper the Friendly Ghost

  John Hopkins | October 27, 2009 9:13 AM | 0 CommentsWest Palm Beach, FL

  “Ghost writing”: a person who writes books, articles, etc. for another who professes to be the author. Drug companies spend billions of dollars advertising drugs that neither I nor you...

• Attorneys have played a role in the FDA’s evolving approach to enforcement

  Armand Rossetti | August 07, 2009 9:45 AM | 1 CommentWest Palm Beach, FL

  Today’s headlines are replete with news about the FDA’s recent commitment to stronger enforcement. I suspect that attorneys’ public comments over the years, concerning the...

• Big Tobacco – the tangled web they weave and the practice to deceive

  John Hopkins | February 27, 2009 11:29 AM | 0 CommentsWest Palm Beach, FL

  It was 1980, but this scene has been going on in “smoke filled rooms” since the early 20th century. Big Tobacco’s Kloepfer and Klopnick were hand wringing; possibly burning the...

• Is Byetta the Next Rezulin or Avandia – Yet Another Promising Drug That Faces Demise Safety Issues

  Brenda Fulmer | November 19, 2008 1:16 PM | 0 CommentsWest Palm Beach, FL

  Those of us who have personally seen the devastating impact of diabetes in our own lives and those of our loved ones are always looking for the next great drug that might provide hope to our...

• The Tequin Mystery

  Armand Rossetti | September 11, 2008 2:42 PM | 2 CommentsWest Palm Beach, FL

  Tequin is an antibiotic used to treat adults with lung, sinus, or urinary tract infections and also to treat certain bacterially generated, sexually transmitted diseases. In recent years,...

• Family Awarded $5.5 Million in Duragesic Patch Suit

  Jenny Albano | June 21, 2007 9:37 AM | 0 CommentsWest Palm Beach, FL

  The father of a man who died while wearing a Duragesic patch was awarded $5.5 million on Tuesday by a federal jury in West Palm Beach. The jury decided that the drug's company was liable for Adam Hendelson's death.The Hendelson family sued Johnson & Johnson subsidiaries Janssen Pharmaceutica Products and the ALZA Corporation over their son Adam's death in 2003. Adam died of an overdose of...