FDA Guidance Reports

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  FDA Guidance for Industry: Medication Guides

  0March 1, 2011
  This guidance is intended to address two topics pertaining to Medication Guides for drug and biological products: When FDA intends to...
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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 programs...
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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...
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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,...
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  FDA DRAFT Guidance for Postmarketing Studies and Clinical Trials – Implementation of 505(o)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  FDA DRAFT Guidance for REMS Format and Content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), including...