Articles

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  REMS Compliance – Review of US REMS Regulation & Compliance

  0July 20, 2010
  FDA regulations regarding risk management have been growing since Thalidomide was found to cause birth defects. The passage of the...
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  Insights and Strategies for a Successful REMS Assessment – Part 2

  0January 22, 2010
  Part 2: Protocol Design The article resumes from Part 1 “Insights and Strategies for a Successful REMS Assessment”. We recommend you...
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  Insights and Strategies for a Successful REMS Assessment – Part 1

  0January 22, 2010
  Part 1: Overview and Assessment Design Since March 2008, the U.S. FDA has taken action on its new authority under the...
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  FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part V)

  0January 18, 2010
  On September 30th, FDA issued draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments...
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  FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part IV)

  0January 16, 2010
  On September 30th, FDA issued draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments...
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  FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part III)

  0January 14, 2010
  On September 30th, FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies...
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  FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part II)

  0January 12, 2010
  On September 30th, FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies...
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  FDA’s Draft Risk Evaluation and Mitigation Strategy (REMS) Guidance – A Preliminary Review (Part I)

  0January 9, 2010
  FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments...