Guide to FDA Drug Safety Regulation, 2018 Edition

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Guide to FDA Drug Safety Regulation, 2018 Edition

The FDA has upped its drug safety game since the last edition of Guide to FDA Drug Safety Regulation, adding more than 30 new, revised and finalized pharmacovigilance guidances, 12 of them in 2015-2017 alone. The new guide has them all:

  • Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data (2013)
  • Form and Content of a REMS Document (2017)
  • Nonclinical Safety Evaluation of Reformulated Drug Products (2016)
  • Providing Postmarketing Periodic Safety Reports in the ICH E2C (R2) Format (2016)

  • Safety Considerations for Product Design to Minimize Medication Errors (2016)

  • Postmarket Submission of Individual Case Safety Reports for Drugs and Biologics (2016)

  • Photosafety Evaluation of Pharmaceuticals (2015)

  • And more…

You’ll also find the long-standing documents on which you’ve built your postmarket surveillance program, including:

  • Development and Use of Risk Minimization Action Plans

  • Good Pharmacovigilance Practices

  • Nonclinical Safety Evaluation of Drug or Biologic Combinations

  • Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients

  • Premarketing Risk Assessment

Guide to FDA Drug Safety Regulation will help you keep up with the FDA’s evolving drug safety requirements as the agency tries to speed drug development and lower prices.

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Who Will Benefit

  • Compliance and regulatory affairs
  • Recall managers
  • Postmarket surveillance staff

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