Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during ...

Risk management is a major emphasis of FDA’s new compliance program, the Quality Management System Regulation (QMSR), and companies should expect to see big differences in how the agency will conduct ...

The U.S. Food and Drug Administration (FDA) recently announced the launch of a pilot program involving abbreviated, one-day inspectional ...

In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...

Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when ...

The core mission of the US Food and Drug Administration’s (FDA) inspections program, as well as how it prioritizes inspections, has remains unchanged despite recent leadership changes at the agency, ...

Counsel advising acquirers in pharmaceutical, biotechnology, and medical device transactions must assess a target's compliance with Food and ...