The Omicron variant has prompted considerable concern and uncertainty in the COVID-19 response, as public health leaders continue to advocate for vaccines and booster shots and researchers make progress in the development of...more
On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” urging drug manufacturers to...more
On September 1, 2020, the Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) held a joint webinar to discuss the jointly-issued Employee Health and Food Safety Checklist for Human and...more
The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities. ...more