Monthly Archives: September 2009

Weekly Roundup – 9-25-09

Posted on September 25, 2009 by Mark Senak

The summer has ended.  On Capitol Hill, however, the hot air continues to blow and blow hard regarding legislation aimed at reforming health care in the United States.  Autumn has arrived and the time has come to plant the mums. … Continue reading →

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What Companies Should Do Between Now and The Part 15 Hearing on Social Media

Posted on September 24, 2009 by Mark Senak

The stunning news of the week has been that the Food and Drug Administration is finally doing what it should have done long ago and called for a Part 15 hearing on social media.  A Part 15 meeting is an … Continue reading →

Posted in FDA Policy, New and Social Media | 2 Comments

How To Register for FDA’s Part 15 Meeting on Social Media

Posted on September 23, 2009 by Mark Senak

According to FDA: 1) Go to www.regulations.gov 2) Search for docket FDA-2009-N-0441-0001 (or type "Internet promotion" in the search box) 3) The search results will display the FR notice and under the "Actions" column on the far right there are … Continue reading →

Posted in Miscellaney | 2 Comments

FDLI Conference Part 4 – The Final Day

Posted on September 23, 2009 by Mark Senak

With the best of intentions, I set out to live blog from the FDLI Conference.  While Day 1 did not afford me an electrical outlet or a dynamic laptop battery, the second day I successfully planted myself next to an … Continue reading →

Posted in FDA Policy | 2 Comments

FDLI Conference Part 3 – Wrap Up of Day 1

Posted on September 22, 2009 by Mark Senak

I had planned on live-blogging from the conference, but there was a paucity of electric outlets at the venue and my battery was exceptionally lazy. Following her speech, during question and answer, I asked Dr. Woodcock the question that was … Continue reading →

Posted in FDA Policy | 2 Comments