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Communicating Information About Agency Procedures - Summary of Public Comments


Background

Transparency Report Arrow Summary of Public Comments

Considerations

View All Draft Proposals for This Topic 


Comments noted that it is important for information about the regulatory process and agency policy to be broadly disseminated.  One comment noted that it is important to bear in mind that providing information to industry trade associations is helpful, but is not sufficient to assure transparency to regulated industry.

Comments offered a range of suggestions for broadly disseminating information, such as providing webcasts of certain meetings hosted by industry trade associations to allow for broader access of the information, online training sessions for individuals who cannot attend training sessions in person, a web portal that provides answers to questions frequently asked by industry, conducting more presentations to industry at the regional level, and posting slides and speaker notes used by FDA employees when giving presentations to external audiences on the FDA Web site.

Several comments suggested that FDA add more detailed FDA organizational charts online so that it is easier for industry to find the right contact person at the agency to talk to about specific regulatory issues, and update organizational charts in a timely fashion when changes in organizational structure or personnel occur.

A couple of comments suggested FDA reinstate its practice of publishing the agency’s strategic plan, with a list of FDA’s priorities for promoting and protecting the public health.

Comments requested that FDA provide information on whom to contact at FDA when a member of industry has a question or an issue.  One comment suggested that FDA develop a “triage” system for quickly and accurately answering industry questions about specific regulatory issues.

Comments also noted that FDA should respond in a timely manner to industry input on vital regulatory issues of concern to industry and the agency.  Comments requested that a system be developed so that questions could be directed to the “FDA expert” on a particular topic and that questions should be answered within a week. 

 

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