The Food and Drug Administration Safety and Innovation Act (“FDASIA”), which was signed into law on July 9, 2012, has serious consequences for the drug industry, particularly in the import/export sector. Some of the changes upcoming from FDASIA include
- Increased generic and prescription drug user fees
- Increasing the information required for drug establishment registration and product listing
- More frequent inspection for foreign drug facilities
Implementation of FDASIA will result not only in the development of new regulations, guidances, and reports, but also in major changes in FDA information systems, processes, and policies.
FDA is holding a …