One Year Since COVID-19: A Roundup

This month marks one year since the United States went into lockdown due to the COVID-19 pandemic.  The industries we serve rose to the occasion, moving many jobs to work from home and ramping up production of critical medicines and devices.  At this time, three vaccines have been approved for emergency use in the United States.

Regulatory agencies also made drastic changes.  Virtual inspections became a major topic of interest for regulated industries.  Even in these challenging times, FDA and other regulators continued enforcement. Still, FDA issued 3,601 483s and 626 Warning Letters in FY2020.

Below is a roundup of our coverage of the COVID-19 pandemic and its impact on regulated industries.

General Updates

• Update: What are Pharma and Med Device Firms Doing About COVID-19
  March 11, 2020 by Amy Filbin
• COVID-19 Briefing: Notes from Covington & Burling March 13 Teleconference
  March 17, 2020 by Marlene Bobka
• COVID-19 Pandemic and Your GMP Audit Schedule for 2020
  March 20, 2020 by Barbara W. Unger
• Big Pharma Puts Patients First in Response to COVID-19 Challenges; Collaboration with Regulators is Essential Going Forward
  March 23, 2020 by Jerry Chapman
• Did COVID-19 Kill Just-in-Time Pharma Supply Chains?
  April 9, 2020 by Barbara W. Unger
• FDA OMQ Regulatory Actions Increase Dramatically in FY2020
  January 5, 2021 by Jerry Chapman

Virtual Inspections

• Yes, FDA is Still Performing Pharma Inspections, Using Risk-Based Criteria: What is Your Risk for Inspection?
  July 2, 2020 by Jerry Chapman
• A State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector
  July 9, 2020 by Jerry Chapman
• Preparing for a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
  July 16, 2020 by Jerry Chapman
• Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
  July 23, 2020 by Jerry Chapman
• Russian Inspectorate Weighs in on Remote Audits and International Harmonization
  January 20, 2021 by Jerry Chapman
• FDA Chooses Not to Perform Virtual Inspections in Contrast with Non-U.S. Agencies
  February 18, 2021 by Jerry Chapman
• Desk Inspections, Missed Action Dates Take Place of FDA In-Person Site Visits
  February 25, 2021 by Jerry Chapman
• Onsite Pharma FDA Inspections During COVID-19 Respect State Restrictions
  March 3, 2021 by Jerry Chapman
• PIC/S GMP Inspection Reliance Guidance Helps Global Agencies During Pandemic
  March 11, 2021 by Jerry Chapman

Webinars

Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends
August 26, 2020 featuring presenter Paul Smith, Agilent Technologies