Questions for FDA by Category
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QUESTIONCATEGORY
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Will ALL the written comments that are submitted to the docket be made available to the public for viewing?0TRANSPARENCY/INFORMATION-SHARING/COMMUNICATION0
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Is the FDA considering creating something similar to the "Open Government" Blog (http://www.whitehouse.gov/Open/Blog/) or HSS' recently-launched "Health IT Buzz" Blog (http://healthit.hhs.gov/blog/onc/) to keep various stakeholders appraised and involved in the guideline development process?0TIMING QUESTIONS1
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Prior to the FDA guidance (if any) will the FDA communicate what they are working on, how they are working, what they are concerned about, what there goals is and what they are considering? 0STEPS/APPROACH/PROCSS IN CREATING GUIDELINES2
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In what timeframe might we expect the the first (draft) guidance be issued after the close of written comments? (3-6 months, 6-9 months, 9-12 months, or further out?)1CONTENT OF GUIDELINES3
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Is there another comment period after the first (draft) guidance is issued? (If so, how long can we expect that to last?)1STAKEHOLDER COLLABORATION4
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Will the first guidance the FDA issues be considered "draft"?2SPECIFIC QUESTION5
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Will the FDA be compiling a summary (not just transcripts) of the hearing presentations and what some of their key takeaways and considerations will be based on?2MISCELLANEOUS6
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Does the FDA plan to pull in any outside consultants, or hire additional experts internally, to help craft the guidelines?2
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Does the FDA plan to conduct any of its own primary research to further assess the benefits-and-risks of various approaches for online communications prior to issuing guidance?2
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Will the draft be shared for comments by industry, consumers, healhcare professionals and bloggers?2
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Given that so many of the ideas shared at the presentations require ongoing studies and experimentation, what kind of resources does the FDA have at its disposal to carry out studies and how much of the work will be give to pharma or agencies so that experiments about AE reporting, correction models, terms of service examples, patient language PIs, patient language adverse event reporting forms, and the like can be done? 2
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Does the FDA intent to work in collaboration with the FTC? Will they actively work with the FTC as opposed to follow the exisisting FTC guidance, as opposed to no consideration given?2
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Knowing the speed at which media changes, is the FDA considering a more regular timeline for reviewing and revising guidance?2
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Is the current plan to organize guidance by topics similar to how the docket was structured?3
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Will the guidance from the FDA take into account the difference between Pharmaceutical and Medical Device companies interacting with current patients whom use products of their manufacture (e.g. patient has pacemaker; patient takes Rx for depression) versus possible patients whom might be appropriate for their specific product.3
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Will the FDA consider the purpose of messaging (pre scrip vs. post script targeted to adherence and focus on health outcome) in the guidelines?3
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What will disclosure rules look like for bloggers and 'tweets' who are paid by pharmaceutical clients to tweet? How must they disclose this relationship?3
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Will the FDA consider creating AE "safe harbor," pending future guidance, that will allow manufacturers to view online conversations about their brands without fear of legal action?3
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Does the FDA plan to proactively reach out to more stakeholders -- patients, public, and physicians in particular -- during the comment period? If so, How will it do that? What can we do to help?4
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Does the FDA plan to reach out to any of the presenters, especially those that presented data, to either request more details or to have the data looked at in a different way?4
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Is the FDA considering a "taskforce/workgroup" - consisting of various stakeholders - to help shape guidance, AS WELL as future post-guidance activities (e.g. like an ongoing advisory board)?4
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Will there be a reflection with "experts" and/or other industries to review the potential possible negative effects of guidance rules?4
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How will FDA collaborate with the FDA advisory board on patient risk communications? And FTC?4
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During the time the FDA is creating its guidance document, will the agency pre-approve search engine ads, especially ads using Google's new format?5
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Are we responsible as the manufacturer for the content created by a 3rd party that's generated at a later date from when we initially linked to their website?5
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What regulatory process is necessary internally to keep up with FDA concerns and how do you recommend we reorganize our internal resources to properly accommodate the massive new social media task of patrolling information; or are we responsible for patrolling 3rd party postings?5
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Social Media crisis situations, what role would the FDA play in reorganizing the madness so that proper health information is disseminated, rather than falsified claims?5
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How will the FDA apply DTC advertising regulations for pharma to social media?5
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How can Pharma find out in a timely way about potential solutions to issues of risk-vs-benefit ie Yaz trying new google paid search format? Can other proceed? How can FDA provide a statement about this so doesn't have to hang until guidelines issued perhaps not for another year.5
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What kind of on-going metrics or actions will be put in place to monitor actions to be sure that any new sm guidelines put in place aren't having a different affect than anticipated? ie the loss of one click rule was showed to have a neg impact on public health not originally planned with the sending of the 14 letters.5
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A lot of discussion has been had concerning, "significant websites" that would be monitored, corrected, from which AEs woul be expected to be tracked. Will the FDA take responsibility for defining what "significant" might mean, or will this definition be created with some external advisory panel? 5
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In a web that has no (US-)borders, how will the FDA define what platforms, information, participants will be governed by FDA regulation or that of non-US regulators?5
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Given web knows no borders, what aspects will define where to report AEs?5
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How will you choose who to engage with industry and beyond for further input to developement of guidelenes for social media and web marketing?5
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What does the FDA intend to do to demonstrate that they truly inderstand the new nature of this emerging media and the impact it has on poeple and businesses?6
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11-30-2009