Jan 6, 2011

In an effort to foster more transparency and communication with the industries it regulates, the FDA has launched a new website, FDA Basics for Industry, to address common questions and concerns regarding regulatory processes.

Major themes featured on the new site include “How do I know if my product is regulated by FDA?”, “What should I expect during an inspection?”, and “I want to manufacture an FDA-regulated product. Where do I start?”

The website’s launch constitutes one of 19 action items recommended in the agency’s report “FDA Transparency Initiative: Improving Transparency to Regulated Industry.” Other items the FDA is pursuing include a policy to respond to email queries within five business days; broader distribution of agency presentations made at meetings; and establishing more consistent processes and procedures across the regulator’s field offices.


  • Stewart Eisenhart