Compliance Glossary

The terms that move markets, trigger investigations, and keep compliance officers up at night.

8-K Filing

An SEC filing that publicly traded companies must submit to announce major events that shareholders should know about.

An FDA advisory committee of external experts that reviews data and votes on recommendations for drug approvals.

FDA notification that the agency will not approve a drug application in its current form, citing specific deficiencies.

A legally binding agreement between FDA and a company, typically requiring specific corrective actions under court supervision.

A document issued by FDA investigators at the end of an inspection listing observed conditions that may violate the Food Drug and Cosmetic Act.

An on-site evaluation by FDA investigators to assess compliance with FDA regulations at manufacturing, testing, or clinical trial facilities.

Buying or selling securities based on material, non-public information in violation of a duty of trust or confidence.

A lawsuit filed by a private person (whistleblower) on behalf of the government against a company that has defrauded the government.

A formal proceeding by the Securities and Exchange Commission against individuals or companies for violating federal securities laws.

An official FDA communication notifying a company of significant regulatory violations that require prompt correction.