FDA Comliance

How to Stay Current with Changing Regulations?

Compliance can be daunting for organizations, especially in a sea of regulations and laws governing their businesses. It needs to be communicated to every level in the organization because the consequences of noncompliance pose huge business risks.Companies are fined millions of dollars in violation of the FCPA, Anti-Corruption, Anti-Money Laundering and [...]

FDA vs. EU Inspections: Similarities and Differences

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009. The program targets investigator sites, sponsors and contract research organizations (CROs) in either the US or the European Union (EU).   These join [...]