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FDA Regulatory and Global Trade

COVID-19 has underscored the interrelationship between consumers and companies across the world. The FDA regulatory and global trade working group is composed of attorneys and scientists who help clients navigate the quickly changing landscape. With scientific knowledge and keen legal acumen, our professionals provide up-to-date information from global public health agencies and practical advice on how to address complicated cross-jurisdictional issues.

Insights

Insights

Updates February 2021

FDA Updates Inspection Guidance with Minor Additions

3 min read  
Media Mentions February 2021

Adrienne Busby Comments on the Future of EUAs Post-Pandemic

2 min read  
Updates November 2020

COVID-19 Weekly Newsletter: Positive Developments in the Race for a COVID-19 Vaccine

7 min read  
Updates September 2020

COVID-19 Weekly Newsletter: Case Count, Death Toll Both Rising as Public Health Officials Work to Instill Confidence in a Vaccine

7 min read  
Updates August 2020

ITC to Investigate Supply Chain Challenges of COVID-19 Products

3 min read  
Updates August 2020

FEMA Extends Halt of PPE Exports Through December 31, 2020

3 min read  
Updates July 2020

FDA to Resume Prioritized Food Facility and Other Domestic Inspections Based on New Risk Assessment System

2 min read  
Updates June 2020

OSHA and CDC Release Interim COVID-19 Guidance for Seafood Processing Industry Workers

4 min read  
Updates June 2020

USDA and FDA Issue Joint Statement on Global Food Export Restrictions and COVID-19 Transmission

3 min read  
Updates June 2020

FDA Amends Imported Non-NIOSH Approved Respirator EUA

2 min read  
Updates June 2020

FDA Revises Enforcement Policy for Face Masks and Respirators

2 min read  
Updates June 2020

FDA Revises EUA Criteria for Respirators Manufactured in China

3 min read  
Updates May 2020

FDA Updates: ‘Conduct of Clinical Trials’ During the COVID-19 Emergency Receives Timely Clarifications and Important Additional Guidance

12 min read  
Updates May 2020

FDA Issues EUA to Increase Availability of Non-Surgical Gowns and Other Apparel

8 min read  
Updates May 2020

Food Labeling Requirements Relaxed for Supply Chain Disruptions During COVID-19

3 min read  
Updates May 2020

FDA, USDA Coordinate to Bring FDA-Regulated Facilities Under DPA Authority

2 min read  
Updates May 2020

FDA Issues Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic

2 min read  
Updates May 2020

FDA Revises EUA Criteria for Respirators Manufactured in China

3 min read  
Podcast May 2020

Sarah Brew Interviewed by HighQuest Partners’s COO Joy O'Shaughnessy on Impact of COVID-19 on Agribusiness

1 min read  
Updates May 2020

U.S. Secretary of Agriculture Issues Letters Addressing Meat and Poultry Packing Expectations

3 min read  
Updates April 2020

President Trump Invokes Defense Production Act to Ensure Continued Operation of Meat and Poultry Processing Facilities

2 min read  
Updates April 2020

CDC and OSHA Outline COVID-19 Safety Practices for Meat and Poultry Workers

2 min read  
Updates April 2020

Employee Illness, Symptoms and Exposures in Food & Ag Facilities: FDA Addresses Workplace Safety During COVID-19

4 min read  
Updates April 2020

Immediate COVID-19 Grant Opportunities Announced by USDA

3 min read  
Updates April 2020

90-Day Customs Duties and Fees Deferrals for March and April Customs Entries

3 min read  
Updates April 2020

FDA Grants EUA for General Purpose Face Masks and Continues to Address PPE Shortage

2 min read  
Updates April 2020

FDA Revises Guidance on Using Ethanol in Hand Sanitizer Products During the COVID-19 Pandemic

4 min read  
Updates April 2020

New Low-Cost Ventilator Approved by FDA for Emergency Use

2 min read  
Updates April 2020

OFAC Releases Updated Fact Sheet on Application of U.S. Sanctions to Provision of COVID-19-Related Humanitarian Assistance

3 min read  
Updates April 2020

China’s Latest Measures for Medical Equipment Exports

2 min read  
Updates April 2020

Another Step in Expanding Personal Protective Equipment: FDA Extends EUA to Face Shields

4 min read  
Updates April 2020

FDA Releases Best Practices for Retail Food Establishments During the COVID-19 Pandemic

2 min read  
Updates April 2020

FDA Expands Use of Certain Non-Cleared Electronic Thermometers During COVID-19 Public Health Emergency

3 min read  
Updates April 2020

FDA Issues Guidance Regarding Modifications to Certain Cleared Infusion Pumps During COVID-19 Public Health Emergency

4 min read  
Updates April 2020

Limited Foreign Supplier Verification Inspections Continue Through Remote Document Review During COVID-19

2 min read  
Media Mentions April 2020

Sarah Brew Discusses the FDA’s Temporary Ease on Food-Labeling Rules During COVID-19 Crisis

1 min read  
Updates April 2020

FDA Opens Door to Respirators From Chinese Manufacturers, Revises Respirator Enforcement Policy

5 min read  
Updates April 2020

FDA Eases Menu Labeling Requirements for Chain Restaurants and Retail Food Establishments During the COVID-19 Pandemic

3 min read  
Updates April 2020

FDA Eases Regulations on Face Masks and Respirators During COVID-19 Pandemic

6 min read  
Updates March 2020

FDA Fact Sheet: Dos and Don’ts of Safely Distributing Human Food for Use as Animal Food

3 min read  
Updates March 2020

FDA Issues Emergency Use Authorization for Ventilators, Tubing Connectors and Accessories

2 min read  
Updates March 2020

FDA Helps the Food Supply Chain by Easing Labeling Requirements During the COVID-19 Pandemic

4 min read  
Updates March 2020

FDA Relaxes Modification Restrictions for Non-Invasive Remote Monitoring Devices During COVID-19 Public Health Emergency

4 min read  
Updates March 2020

GOP Advocates for Trade Relief for Companies Impacted by COVID-19

3 min read  
Updates March 2020

FDA Continues to Respond to Food Industry COVID-19 Concerns: Employee Testing, Social Distancing, Sanitizer Alternatives and Masks

4 min read  
Updates March 2020

Responses to the Current Ventilator Shortage: FDA’s Recommendations and Guidance for Industry and Health Care Providers

6 min read  
Updates March 2020

FDA and TTB Take Steps to Ease Hand Sanitizer Shortage

5 min read  
Updates March 2020

FDA Issues Final Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

3 min read  
Updates March 2020

FDA Responds to COVID-19 Concerns: Our Food Supply Is Safe

4 min read