FDA Unveils First Phase of Transparency Initiative

The U.S. Food and Drug Administration today unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process.

During an online presentation, the chair of the FDA’s Transparency Task Force, Principal Deputy FDA Commissioner Joshua Sharfstein, described a Web-based curriculum called “FDA Basics,” aimed at helping the public better understand what the agency does. The curriculum is accessible via a link on the FDA Web site.

The curriculum includes:

• Questions and answers about the agency and the products it regulates
• Short videos that explain various agency activities
• Conversations with agency personnel about the work of their office

In addition, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions. Each of these sessions will be announced on the FDA Web site.

In one of her first acts after assuming the office last spring, FDA Commissioner Margaret A. Hamburg, M.D. announced the formation of an internal task force to develop recommendations for enhancing the transparency of the FDA’s operations and decision-making processes.

As more digital pathology applications are targeted at clinical applications, the role of the FDA in regulating the vendors and products in the space becomes ever more important.  This additional transparency is a welcome step, seems like it will benefit everyone.  Ideally the FDA and vendors work together to ensure safe and effective products are brought to market.