Surviving a new era of FDA enforcement

摘要

Receiving a Warning Letter from the U.S. Food and Drug Administration is concerning enough, but when those Warning Letters are published on the agency's Web site, where companies can read, print out, and use them for competitive advantage, the "incentive" is even greater for companies to take corrective action. Since 2009, FDA's increased power and budget have led to more seizures, injunctions, Warning Letters, and recall events, with penalties enforced to discourage future offenses. More inspections and public enforcement actions-even YouTube videos-are part of the new strategy the agency hopes will ultimately help safeguard consumers of healthcare-focused products.