Home > Transparency Posts > Upcoming Events: Task Force is Holding its Second Public Meeting on Transparency in November

Upcoming Events: Task Force is Holding its Second Public Meeting on Transparency in November

Upcoming Events: Task Force is Holding its Second Public Meeting on Transparency in November

The next public meeting on transparency will be held Tuesday, November 3, 2009. The task force plans to use a discussion group format to receive detailed and in-depth comments on three specific issues related to transparency at FDA. The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (i.e., no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications.

For each topic, a panel will discuss a case study about the topic and answer questions that may be posed by task force members. Audience members will also have an opportunity to comment and ask questions following each discussion group.

The meeting will be held from 9 a.m. to 3 p.m. at the National Transportation Safety Board (NTSB) Conference Center in downtown DC. You can find information about participating in the meeting and/or submitting comments to the task force here. The task force is also looking into webcasting this meeting.

We look forward to you participation.

Transparency Task Force

  1. Anne Patenaude
    October 5, 2009 at 8:00 am

    Ed Silverman’s Pharmalot
    Full disclosure lacking ‐ Apotex says the FDA issued an import alert about its products, BUT doesn’t mention which ones http://bit.ly/Tg3Lp8:07 AM Sep 15th from bit.ly
    Would it be possible for the FDA to provide – post- a list of the reported 40 Apotex generic drugs from their North York and Etobicoke facilities that have been put on FDA Import Alert?
    Are these drugs still in distribution and dispense channels? If so, which ones and how much supply?
    Are these APO drugs still available to patients who may order their medicines from the Internet? Isn’t this the time of year when many Medicare patients hit the ‘donut hole’ and might order their medicine from the Internet?

  2. Kristine Maxwell
    October 7, 2009 at 8:19 pm

    Here’s a great suggestion for providing important and helpful information to consumers. Place the MedWatch 3500A forms on line for all the public to see concerning drugs. You already provide this information for medical devices. Consumers and Doctors need to know about the MedWatchs that are being filed concerning FDA regulated drugs. The system now is in ascii which is outdated and cumbersome. This data is NOT helpful to consumers and physicians.

  3. gold
    October 28, 2009 at 1:19 pm

    I really hope you guys can get the webcast to work because I don’t live in DC but am very interested in this topic. I love your embrace of Web 2.0 on this site!

  4. kate miller
    October 28, 2009 at 7:18 pm

    The FDA is a government entity that no longer can handle the job of overseeing the food supply and the drugs that are supplied and created for America’s consumption.The transparency will need to start with governmental change in regards to how drugs are followed once approved.We all assume that drugs are deemed safe if they make it to market,that is not true.In many ways the approval of a drug should go further than the clinical trial,the follow up on the success and safety profile can only be determined once it goes out to the masses ,population response is very telling.The FDA must change policy in drug approval to be able to be successful with it’s transparency efforts.We have found that when a drug is suspect in having postmarketing problems,the FDA makes a vague announcement and communicates these problems on a very small scale.We need transparency and better communication of serious adverse event reports to protect the public from the unlikely yet sad events that can occur to the illinformed consumer.Kate Miller

  5. jerome
    January 23, 2010 at 5:03 am

    nice information thanks

  6. Mido
    August 31, 2010 at 6:41 pm

    Great article very useful for me
    thank you

  7. Eric Weikel
    January 28, 2012 at 9:35 am

    Thank you for sharing this useful information. The article was extremely helpful and i surely look forward to obtaining more information in the future. Thanks again.


  8. seanrohan77
    July 11, 2013 at 9:00 pm

    Great article. Thank you.

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