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Trends
Update: What are Pharma and Med Device Firms Doing About COVID-19?
March 11, 2020
Enforcement
Warning Letters Week of 3/1/2020: Device Design Controls
March 10, 2020
Enforcement
FDA Warning Letters Week of 2/23/2020: After 3-Week Absence, 8 to Drug and Device Firms
March 3, 2020
Enforcement
The Importance of Monitoring Import Alerts
February 26, 2020
Conference Spotlight
Part 2: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries
February 25, 2020
January 483s: Most Popular and Newsworthy
February 13, 2020
Enforcement
FDA Warning Letters Week of 2/2/2020: Device Repeat Deficiencies
February 11, 2020
Enforcement
FDA Warning Letters Week of 1/26/2020: HCT/P and OTC Products
February 4, 2020
GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues
January 30, 2020
510k – What is the FDA 510(k) Premarket Notification?
January 24, 2020
Enforcement
FDA Warning Letters Week of 1/12/2020: CMO Quality
January 21, 2020
December 483s: Most Popular and Newsworthy
January 15, 2020
Enforcement
Warning Letters Week of 1/5/2020: Data Discrepancies
January 14, 2020
Conference Spotlight
How to Talk So That FDA Will Listen, and How to Listen When They Talk: Advice That Could Be Worth Millions
January 10, 2020
November 483s: Most Popular and Newsworthy
December 27, 2019
Enforcement
FDA Warning Letters Week of 12/15/2019: Independent Assessment Requests
December 23, 2019
Enforcement
FDA Warning Letters Week of 12/8/2019: CAPAs, Complaints, and Quality Systems
December 17, 2019
Enforcement
FDA Warning Letters Week of 12/1/2019: Cell and Tissue Therapies
December 10, 2019
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