FDA Unveils First Phase of Transparency Initiative

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

During an online presentation, the chair of 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 here.

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.

The Transparency Initiative was launched in response to the Obama Administration's commitment to an unprecedented level of openness in government and with the strong support of the Department of Health and Human Services.

"This initiative will make information about the FDA more user-friendly and accessible to the public," Hamburg said. "It fosters a better understanding about what we do."

In recent months, the Task Force solicited public input on improving agency transparency through a public docket, an online blog, and two public meetings. The Transparency Task Force received hundreds of comments from various stakeholders, including regulated industry, consumers, patients, health care providers, and others. As a result of comments from the public, the Task Force decided to develop its recommendations in three phases. FDA Basics represents the result of the initial phase, to be followed by two additional phases.

In phase two of the initiative, the Task Force intends to make recommendations to the commissioner regarding how to make information about agency activities more transparent, useful, and understandable to the public, in a manner compatible with the agency's goal of protecting confidential information, as appropriate.

In the final phase of the initiative, the Task Force intends to make recommendations to the commissioner regarding FDA's transparency to regulated industries.

For more information about the Task Force, visit www.fda.gov/transparency.

Product Showcase

  • Magellan X Pte Ltd

    Hesitate No More with SOL-X Connected Worker Health & Safety Solution

    According to the National Safety Council, work-related medically consulted injuries total 4.26 million in 2021 in USA alone. SOL-X solution prevents “human factors” safety issues by anticipating incidents and improving compliance workflows. Leverages digital technologies (IIoT, AI and analytics) to predict patterns from occurring and make informed decisions. Control Of Work - gets rid of tedious paperwork and experience digital workflows. Crew Protect - maximises safety and situational awareness with health trackers and situational indicators. Award-winning Intrinsically Safe SmartWatch – innovative features that enable near real-time visibility and connected well-being. Works well with major connectivity protocols like Wi-Fi, Bluetooth, and Long-Range Bluetooth! 3

  • The MGC Simple Plus

    The MGC Simple Plus

    The MGC Simple Plus is a simple-to-use, portable multi-gas detector that runs continuously for three years without needing to be recharged or routinely calibrated after its initial charge and calibration during manufacturing. The detector reliably tests a worksite’s atmosphere for hydrogen sulfide, carbon monoxide, oxygen and combustible gases (LEL). Additionally, it is durable enough to withstand the harshest treatment and environments, which is why it has an IP 68 rating. The MGC Simple Plus is also compatible with a variety of accessories, such as Gas Clip Technologies’ new GCT External Pump. Visit gascliptech.com for more information. 3

Featured