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After a Series of False Starts, FDA Resumes Domestic Inspections

FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more

FDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered Risk Assessments

The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more

FDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics

In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

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