Category: COVID-19

FDA Guidance Details Exemptions and Exclusions from Certain Drug Supply Chain Security Act Requirements Due to COVID-19 Public Health Emergency

On April 30, 2020, the U.S. Food and Drug Administration (“FDA”) published guidance clarifying the nature and scope of exemptions and exclusions to certain requirements under the Drug Supply Chain Security Act (“DSCSA”) triggered by the COVID-19 public health emergency. By waiving certain requirements under the DSCSA for the duration […]

OCR Issues Additional Guidance Regarding Enforcement Discretion in Connection with COVID-19 Community-Based Testing Sites

On April 9, 2020, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) announced that it will exercise its enforcement discretion and not impose penalties on covered entities or their business associates for noncompliance with Health Insurance Portability and Accountability Act (“HIPAA”) regulatory […]