Archive

Archive for June, 2009

Watch and Comment on the Task Force’s Public Meeting

June 23, 2009 14 comments

For those of you who are unable to attend the public meeting in person, the Task Force has made the meeting viewable via webcast. The link to the live program will not be active until June 24, 2009, at 7:30 AM ET. For details on the day's events please view the meeting's agenda.

We look forward to your participation.

Erik P. Mettler, MPA, MPH

FDA Transparency Blog Managing Director

The Transparency Task Force’s Sixth Question

June 23, 2009 16 comments

We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The sixth question is:

What metrics should FDA use to gauge the effectiveness of its transparency efforts?

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

The Transparency Task Force’s Fifth Question

June 23, 2009 3 comments

We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The fifth question is:

As FDA becomes more transparent, what information should remain confidential in order to promote key internal and external policy goals, such as preserving patient privacy, and how, in these cases, should FDA explain the importance of confidentiality?

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

Ground Rules for June 24 Public Meeting on Transparency

June 22, 2009 20 comments

-  This public meeting is about transparency at FDA, how the agency can make understandable and useful information available to the public. Comments should be limited to this topic.

- Comments should be limited to 5 minutes to permit adequate time for questions from the panel and to allow time for an open comment session later in the day.  During the open comment session, attendees who did not register to speak can make comments.

-  Registered speakers will be organized into panels of three.  We have attempted to group registered speakers thematically, based on the brief description each speaker provided when he or she registered to speak.  Admittedly, this is an imperfect science and speakers in some groups may be speaking on different topics.  

- FDA panelists may ask questions to the panel after all three speakers finish delivering their comments.

- We are looking forward to a respectful discussion and exchange of ideas. 

- Under no circumstance shall a speaker be interrupted by another attendee at the conference. 

- Personal attacks or disparaging comments will not be permitted.

- Comments to the panel should be made only when at a microphone and you have been recognized by the Chair of the meeting.

- The public meeting is being webcast and there will be a verbatim transcript of the meeting publicly available. Do not share or reveal information you would not want to be public.

- In addition to the public meeting, there are other ways to provide comments to the task force.  You can post comments to this blog, submit written comments to the Division of Dockets Management, or submit electronic comments to Docket No. FDA-2009-N-0247 at www.regulations.gov.  Information about submitting comments to the task force can be found in the June 3, 2009 Federal Register Notice.

We look forward to your participation at the public meeting on June 24.

Afia Asamoah, JD, MPP
Public Meeting Coordinator

The Transparency Task Force’s Fourth Question

June 21, 2009 23 comments

We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The fourth question is:

 

What, if any, legislative or regulatory changes are needed to improve FDA's ability to provide useful and understandable information to the public?

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

Would you like to have a statement read at the the Task Force public meeting?,

June 18, 2009 9 comments

If you cannot attend the public meeting on transparency in person and would like to have a statement read at the June 24th Transparency Task Force public meeting, please email that statement to Transparency.Meeting@fda.hhs.gov. The statement will be read to the Task Force by a FDA staff member during the public meeting. The statement should be 5 minutes or less so we can accommodate all people who want to speak.

 

Note: Statements should be submitted by 5 p.m. Monday, June 22.

 

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

 

 

The Transparency Task Force’s Third Question

June 18, 2009 14 comments

We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The third question is:

 

What tools, techniques, processes, or other mechanisms should FDA use to be more effective in providing useful and understandable information?

  • Internet tools?
  • Tools to improve targeting and effectiveness of communications, including risk communication?
  • Improvements to the Freedom of Information Act processes?
  • Other?

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

Response to Some Comments

June 16, 2009 18 comments

In response to a few of the comments that have come in we have added a new section to the “About This Blog” page. On that page you will now find a description of the Task Force’s Actions and Membership. We will also provide a webcast of the Public Meeting on the 24th. The link to the webcast will provided here in a separate post as well as on the Task Force website. The webcast will also be available for viewing online after the public meeting.

If you have any other suggestions on how we can improve this blog and make it more useful please let us know.

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

The Transparency Task Force’s Second Question

June 14, 2009 16 comments

We want to know what information FDA could give to the public to better explain the agency’s work and its decisions. The second question is:

What specific information should FDA provide about agency operations, activities, processes, and decision making, including:

  • Enforcement Actions?
  • Product Approvals?
  • Recalls?
  • Other Actions?

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

Transparency Public Meeting Structure and Format

June 8, 2009 17 comments

We are seeking advice on the best way to structure the June 24, 2009 public meeting on transparency.

The agency typically organizes public meetings by the order in which presenters submit their speaking requests to the agency.  This approach has varied results as it can be difficult to locate a particular meeting or to review comments associated with a particular topic after the meeting.  We have come up with additional options below for organizing the June 24 public meeting and we are interested in your input.

  • By Product (e.g., drugs/biologics, medical devices, foods, cosmetics, dietary supplements)
  • By Agency Action (e.g., review of product applications and product approvals, enforcement actions, recalls, public education and outreach to stakeholders)
  • By Question posed in the Federal Register notice

Thank you in advance for your help and advice.

FDA Transparency Task Force

Follow

Get every new post delivered to your Inbox.

Join 171 other followers

%d bloggers like this: