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FDA 2015: A Look Back (and Ahead), Part 1

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Since March 2015 it’s been my pleasure to serve as the Food and Drug Administration’s (FDA) Acting Commissioner. The FDA has broad responsibilities, and I’d like to share some important accomplishments during 2015.

What We Mean When We Talk About ‘Data’

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When Inspections and Regulations Leave Quality Lacking, Try This

  • Read more about When Inspections and Regulations Leave Quality Lacking, Try This
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Improving FDA Reviews of Combination Products

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Ten Tips to Prepare for Electronic Health Records Audits

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Does Every Good Analytical Chemist Need to Be a Statistician?

  • Read more about Does Every Good Analytical Chemist Need to Be a Statistician?
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I read trade publications that cover everything from banking to biotech, looking for interesting perspectives on data analysis and statistics, especially where they pertain to quality improvement.

Cybersecurity—A Real Threat to Medical Devices

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Congress Crawls Out of 20th Century to Push Bipartisan ‘Cures’ Legislation

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Should the FDA Get Tougher on Investigational Review Boards?

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The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.

FDA Plays Catch-Up

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Pagination

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