Three months in, most medical device manufacturers have completed their initial gap assessments — but the harder work is only ...

Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated ...

The Food and Drug Administration has released new produce regulatory program standards to help align state and federal inspections. The standards cover inspector training, foodborne illness response, ...

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, Inspection of Medical Device Manufacturers (CP 7382.850), to explain how the ...

Key steps for organizations and their counsel to take and issues to consider when developing and implementing a risk-based due diligence program for investigating third parties in commercial ...

The United Kingdom has initiated a risk-based inspection program targeting online pharmacies and healthcare service providers. Officials at the Care Quality Commission (CQC) began the operation after ...

A study has found an association between violations of food safety legislation and a company’s weak financial situation. The work investigated the link between the financial situation of Finnish ...

The Drug Controller General of India (DCGI) has scrapped the need for manufacturers to undergo a joint inspection before receiving certain biologics licenses. Instead of conducting pre-approval visits ...