Final Phase of the Transparency Initiative: We Want Your Ideas
As part of the final phase of the Transparency Initiative, we are looking for ideas from the public on how FDA can increase transparency with regulated industry, in order to foster a more effective and efficient regulatory process. These comments will be used to inform draft recommendations the Task Force will put forward this spring on ways FDA may improve transparency to regulated industry.
FDA regulates products responsible for about 25 percent of the gross national product of the United States and the industries responsible for these products. Products regulated by the agency – biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines – are integral to public health and to the U.S. economy.
The Task Force held public meetings in June 2009 and November 2009. Based upon input received so far, the Transparency Initiative has been divided into three phases. The first phase, creating a Web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed. The second phase, improving FDA’s disclosure of information to the public, is underway and FDA intends to issue draft proposals for public comment soon.
For this final phase, we are particularly interested in comments on how FDA can make improvements in certain areas. The first area we would like to hear comments about is:
What training and education should FDA provide for regulated industry about the regulatory process in general, or about new requirements?
We will post additional topics over the next couple of weeks.
We look forward to your ideas.
Transparency Task Force