ICH Q10 - Pharmaceutical Quality Systems - 'An Opportunity for Us All'

November 15, 2019
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Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments
Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

The U.S. Food and Drug Administration has released data on the most common observations it makes during ins...

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FDA Experts Offer Top Tips to Optimize Your eCTD Submission
FDA Experts Offer Top Tips to Optimize Your eCTD Submission

This white paper shares 12 tips for a successful eCTD submission based on a presentation by an FDA official.