On Friday, March 13, 2020, Covington & Burling hosted a Briefing Call titled “COVID-19: Evolving Considerations for the Life Sciences Industryspearheaded by the firm’s Food, Drug and Device industry practice.  Contributors cited were Grant Castle, Denise Esposito, Nigel Howard, Mike Imbroscio, Jen Plitsch, and Paula Katz.

The discussion was wide-ranging and made some important points. We cover these below.

FDA’s New Authority

The March 4  State of Emergency declaration made by Alex Azar, Secretary of Health and Human Services gave FDA broad new authority. Some of the powers of interest allow FDA to grant Emergency Use Authorizations (EUAs) which allow new products/indications etc. onto the market without the usual applications normally applicable to drugs, devices, diagnostics, and biologics. FDA will work with manufacturers to evaluate evidence of safety and effectiveness at hand; companies may be allowed to proceed to market using, for example, anecdotal evidence or incomplete clinical trials. The decision will depend on a risk assessment and documentation of evidence at hand, but FDA is amenable to working closely with firms and waiving the usual requirements.

Lawsuit Immunity

Manufacturers with emergency product clearances are eligible for immunity from lawsuits resulting from products cleared under the declaration.

Contract Development

Money is available to enter into contract development with agencies within HHS and manufacturers should examine the contracts carefully to determine how using government funding will affect intellectual property, especially patents. Many normal contract restrictions, e.g. sole source, small business set-aside, can be lifted.

GxP Flexibility

FDA is also being flexible with GxP considerations as long as an alternate plan is documented; e.g., quality review done by teleworking rather than in-person supervision. Deviations in GCP are expected in clinical trials (recruitment, in-person assessments) as long as protocol changes are documented and the risk is assessed; trial sponsors should work with their IRB and FDA.

Reporting and Shortages

Reporting requirements remain in place, especially in the case of shortages and FDA expects to hear about expected and actual shortages. For supply chains, they will relax rules specifying outsourcing goods and services as long as risk assessments are in order. 

Inspections and Desk Audits

Foreign inspections, except for “mission-critical” inspections, have been postponed. A slowdown in domestic inspections is also expected; FDA is considering the use of desk audits, relying on specified documentation from the manufacturer.

Covington & Burling experts invite questions from health industry manufacturers. Contact information is available at www.cov.com.

NOTE: Shortly after the Covington & Burling briefing, FDA announced that Roche had become the first commercial test developer to achieve EUA status for a diagnostic test for COVID-19 in an application granted within 24 hours of agency receipt. In another update Friday, FDA Center for Devices and Radiological Health Director Jeffrey Shuren said over 60 developers have worked with the agency on potential EUA submissions, and more than 30 labs have said they plan to begin testing under the recent FDA coronavirus policy allowing use of pre-EUA lab-developed tests.

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Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

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In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

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—Stephanie Gaulding, Pharmatech Associates

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This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

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  • Common challenges small pharma firms face when developing a QMS
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In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

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Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

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Past, Present, and Future of Quality Culture

Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp

What you will learn:

  • How the 2014 FDA quality metrics initiative led to greater focus on quality culture
  • New quality culture tools and standards under development by PDA and other organizations
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Changing Medical Device Regulations

Presented by Redica Systems 

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  • The latest developments regarding the EU MDR
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Combination Product Report

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The latest U.S. and European regulatory developments

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5 GMP Case Studies Report

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A.I. for Quality and Compliance Teams

August 3 webinar

Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman

What you will learn:

  • A basic understanding of data sources, machine learning, NLP, and A.I. tools
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Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
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  • International strategies: expectations for human factors in regulatory submissions in international markets

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