The EPA Drug Initiative Press Releases

• Published on February 13, 2014 - 14:25 GMT

  

  The Vascepa sNDA... An Open Letter to Dr. Janet Woodcock, Dr. Curtis Rosebraugh and Dr. Stephen Ostroff

  AIM-HIGH, ACCORD-Lipid and HPS2-THRIVE do not support FDA's claim that high TG-lowering in the ANCHOR population will likely not result in clinical benefit. HOUSTON, TX, USA, February 13, 2014 /EINPresswire.com/ -- A lawyer's perspective: …

  Distribution channels: Healthcare & Pharmaceuticals Industry, Law ...
• Published on February 13, 2014 - 14:25 GMT

  

  The FDA Misunderstands Science – Endangers Millions of Patients

  FDA has no legitimate scientific or medical grounds to refuse Vascepa sNDA approval. Physician asks FDA to work towards a more logical, fact-based solution. NEW YORK, NY, USA, February 12, 2014 /EINPresswire.com/ -- …

  Distribution channels: Banking, Finance & Investment Industry, Healthcare & Pharmaceuticals Industry ...
• Published on February 10, 2014 - 14:32 GMT

  

  "Amarin's Vascepa: Serious FDA Safety and Efficacy Issues - Really?‎"

  A Letter to Dr. Margaret A. Hamburg, FDA TAMPA, FLORIDA, USA, February 10, 2014 /EINPresswire.com/ -- I want to express my concerns regarding the FDA actions relating to Amarin (AMRN). I approach this not as a medical professional but rather as an …

  Distribution channels: Banking, Finance & Investment Industry, Consumer Goods ...
• Published on February 10, 2014 - 11:57 GMT

  

  Doctors and Patients Petition FDA to Approve Amarin’s Vascepa for High Triglycerides

  Amarin is Appealing to The Office of Drug Evaluation II – Dr. Curtis Rosebraugh NEW YORK, NY, USA, February 10, 2014 /EINPresswire.com/ -- Below is a selection of the many comments that we have received from health care workers and patients in relation to …

  Distribution channels: Business & Economy, Consumer Goods ...
• Published on February 4, 2014 - 10:04 GMT

  Consumer Group Challenges FDA to Abide by Its Own Guidelines

  Urges Reinstatement of SPA for Heart Drug Vascepa NEW YORK, NY, USA, February 4, 2014 /EINPresswire.com/ -- The EPA Drug Initiative (EPADI) asserts that the FDA did not live up to its own scientific integrity standards in rescinding the Special Protocol …

  Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
• Published on December 12, 2013 - 15:03 GMT

  An Open Letter to Dr. Margaret A. Hamburg, FDA Commissioner

  NEW YORK, NY, USA, December 12, 2013 /EINPresswire.com/ -- FOR IMMEDIATE RELEASE An Open Letter to Dr. Margaret A. Hamburg, FDA Commissioner December 12, 2013 The U.S. Department of Health and Human Services 200 Independence Avenue, S.W. …

  Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...