Now that the big FDA public hearing is over, many people are asking “What’s the next steps?” If you are like me, you expect FDA to issue new guidance. My friend John Murray has outlined the usual process FDA goes through when developing guidance here.
But some of us are anxious to see if stakeholders can get more involved in the process. For example, does the FDA plan to pull in any outside consultants, or hire additional experts internally, to help craft the guidelines? There are other questions as well, like Will there be an additional comment period after draft guidelines are published?
I learned that FDA Intern, strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even former FDA commish Andy von Eschenbach, is also on a quest to determine the next steps!
FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!
Ask FDA Your Questions About What’s Next
Everyone wants to know what happens next as the FDA deliberates what, if any, guidance it should draft regarding the regulation of Rx drug and device promotion on the Internet and social media.
We have questions like:
* Will new guidelines be drafted before the end of 2010?
* Will FDA seek help by forming a special working group?
While the FDA may not be able to fully answer all these questions, they would appreciate receiving questions from a single source in order to expedite their replies. It certainly will help them understand the concerns.
Volunteers in concert with www.fdasm.com developed a survey/questionnaire to collect these questions in one place and forward them on to the appropriate people at the FDA.
Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.