#hcsm – January 15, 2012

Watch the live #hcsm stream from January 15, 2012 at 8pm Central here (new window). If you missed the chat, you should be able to come back and scroll through it again, any time. (Availability of archive depends on how Twitter API is working during the chat. I recommend searching for #hcsm directly on Twitter in real-time to watch/participate in the chat.)

Tonight we’re discussing the recent FDA guidance on unsolicited requests for information.

FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date  information about the firm’s products.

Topics:

  1. What do you think about their choice for the first draft guidance – responding to unsolicited requests?
  2. Think about the content w/in the guidance itself. Is it clear to pharma what’s best practices vs. not? What would you add or clarify?
  3. Many people were hoping for larger guidance & more structure from FDA. What should come next from FDA?

Don’t forget – if you’d like to submit a topic for a future #hcsm chat, you’re welcome to! Read the details on the different ways to submit a topic for a #hcsm chat. Also, if you missed the chat, or want to add additional thoughts & feedback to the above discussion topics, leave a comment & keep the discussion going!

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