FDA launches Basics for Industry Website

The U.S. Food and Drug Administration launched a new website called FDA Basics for Industry. On these web pages a lot of information is provided about the FDA, its responsibilities, expectations and regulatory processes.

They provide a very good overview and easy access to topics like:

• What does FDA regulate (and what doesn't FDA regulate)
• How to register facilities and products
• How to update registrations
• How to provide input for Guidance development and possible topics for future Guidance development
• How to submit questions or comments
• The Dispute Resolution Process
• The Product Application and Petition Review Process
• What should be expected during an inspection?

The website is of particular interest for drug manufacturers just getting into the business, or those who manufacture outside the United States and want to sell their products in the US. But also for everybody else who wants to get quick access to almost all relevant information provided by the agency.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)