17 May 2019 - Consumers must have confidence in the safety and quality of generic medicines. 

They also rely on FDA’s regulatory systems to ensure the quality and safety of globally produced drugs even before those products are on the market. Generic drugs are just as safe and effective as their brand counterparts and FDA stands behind the rigorous standards and regulatory inspections that go into ensuring the safety and quality of all generic drugs. These standards and inspections apply equally to generic and innovator drugs — domestically and around the world.

FDA has implemented a modernised approach to ensure and enhance adherence to these standards and to keep up with continuous globalisation and increasingly complex supply chains. Through Program Alignment, FDA’s Office of Regulatory Affairs (ORA) has modernised its workforce and approach to improve public health in a way that keeps pace with the acceleration of scientific innovation, global expansion of markets, and new programmatic mandates.

Read FDA blog