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New Guidance Manufacturing Facilities

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Robinson+Cole Manufacturing Law Blog

OSHA Publishes Updated COVID-19 Guidance

On June 21, 2021, OSHA made big news by publishing its COVID-19 Emergency Temporary Standard for the Healthcare Industry (ETS). While the ETS does not apply to most manufacturing facilities, OSHA also updated its general...more

McDermott Will & Emery

Special Fraud Alert: OIG Raises Concerns with Speaker Programs

McDermott Will & Emery on

In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more

King & Spalding

COVID-19: New OSHA/CDC Guidance For Manufacturing and Industrial Facilities

King & Spalding on

On May 12, the United States Department of Labor’s Occupational Safety and Health Administration (“OSHA”) and the Centers for Disease Control and Prevention (“CDC”) issued joint “interim” guidance for manufacturing and...more

BCLP

FDA and USDA Guidance on Worker Safety and Sanitation in Food Production Facilities

BCLP on

As the COVID-19 pandemic has continued to escalate, both the Food and Drug Administration (“FDA”) and the U.S. Department of Agriculture (“USDA”) have issued guidance and public statements advising manufacturers and...more

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