Archive for January, 2010

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  ParagonRx, an InVentiv Health company

  0January 24, 2010
  Key contact: Karen Lenoir Client Services Director ParagonRx, an inVentiv Health Company Little Falls Centre Two 2751 Centerville Road, Suite...
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  Mitigate Medical Product Risk and Improve Safe Use

  0January 22, 2010
  Abstract The adequacy of labeling for instructions, cautions, and contraindications becomes pivotal in the benefit/risk assessment of medical products. Our...
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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...
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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...
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  FDAAA Law Public Law 110-85

  0January 22, 2010
  September 27, 2007 An Act: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee...
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  FDA Procedures: SOPP 8413: Postmarketing Commitment Related Submissions – Administrative Handling, Review, and CBER Reporting

  0January 22, 2010
  The purpose of this document is to describe the procedures for administrative handling and regulatory review of postmarketing commitment (PMC)...
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  FDA Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

  0January 22, 2010
  This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological...
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  FDA DRAFT Guidance for Postmarketing Studies and Clinical Trials – Implementation of 505(o)

  0January 22, 2010
  This guidance provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the...
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  FDA DRAFT Guidance for REMS Format and Content

  0January 22, 2010
  This document provides guidance to industry on: The format and content of a proposed risk evaluation and mitigation strategy (REMS),...
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  FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices

  0January 22, 2010
  The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to...