FDA is proposing to expand disclosure of certain information which is currently not openly shared with the general public. The twenty-one draft proposals are in response to comments received by FDA’s Transparency Task Force as a way to make the decision-making of the FDA more apparent to consumers and regulated industries. The proposals are available on-line as a complete report or by specific topic area.
The report divides the draft proposal into the following eight general topic areas:
- Adverse Event Reports
- Docket Management Process
- Enforcement Priorities and Actions
- Import Procedures
- Product Applications (including Investigational applications)
- Warning and Untitled Letters
Ten of the twenty-one draft proposals are applicable to the food industry. They are listed below with links provided to background information, summary of public comments, agency considerations and reasoning for the draft proposal.
FDA is accepting comments on the proposals through July 20, 2010.
Co-authored with Dean Leaman, Director of Business Development
Import/Export – Miami, FL, ABC Research Corporation