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 public meeting on July 12th to receive input and feedback on Title VII. The purpose of the meeting is to provide an overview of Title VII, discuss how FDA plans to implement it, and hear public comment about those provisions that specifically address imported drugs and importers. Attendance is free and will be on a first come, first served basis. Individuals who wish to present at the public meeting must register on or before July 5, 2013.
Those who wish to attend can register for the meeting here. If you are unable to attend the meeting, or would like more information on how these new authorities and requirements will affect your business, contact us to discuss the upcoming implementation.
