FDAzilla GMP Regulatory Intelligence Newsletter

FDAzilla GMP Regulatory Intelligence Newsletter
FDAzilla GMP Regulatory Intelligence Newsletter2019-01-24T16:12:39+00:00

Latest Issue

MONTHLY SCAN | September, 2019

Happy Reading, Barbara FDA: DEVICES: The FR announced availability of a final guidance, ‘Acceptance Review for De Novo Classification Requests’. DEVICES: The FR  announced availability of a final guidance, ‘FDA and Industry Actions on De Novo Classification Requests:  Effect on FDA Review Clock and Goals.’ DEVICES: The FR announced availability of a final guidance ‘User Fees and Refunds for De Novo Classification Requests.’ DEVICES: The FR announced availability of a final guidance, ‘Humanitarian Device Exemption Program.’ DEVICES: The [...]

By |October 10th, 2019|Categories: Monthly Scans|0 Comments

Special Reports

July 16th, 2018|0 Comments

Warning Letters for the First Half of 2018 This article summarizes warning letter enforcement actions in the first half of [...]

June 4th, 2018|0 Comments

The U.S. Food and Drug Administration (FDA) identified failures in data governance and data integrity starting approximately 20 years ago. [...]

  • FDA17 Enforcement Analytics Summary

June 4th, 2018|0 Comments

FDA Enforcement Statistics Summary, Seizures, Injunctions, Warning Letters, Total Recall Events, Total Recalled Products, Recalls

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