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.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Easy to Use Safety Incident App

    Record incidents on the go with IndustrySafe’s mobile app. Collect data for multiple types of incidents including including near misses, vehicle and environmental incidents, and employee and non-employee injuries; at job sites and remote locations—with or without web access.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. IndustrySafe is here to help. We put together a resource that’s easy to digest so you can get answers to your training questions and ensure you're complying with OSHA's standards.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus