Tag Archive: transparency

Jan 17 2011

New Informed Consent Requirements Improve Transparency in Clinical Trials

Trust, honesty, humility, transparency and accountability are the building blocks of a positive reputation. Trust is the foundation of any relationship. – Mike Paul Transparency of clinical research to participants and patients is what the FDA is going for with their amended informed consent regulations. The new regulations stem from the Food and Drug Administration …

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Aug 02 2010

Safety Data and Transparency

For the safety of all the public, for the safety of our officers, we need to understand intimately all that can be learned – William Bratton You may have noticed that transparency has been a topic of interest lately (for summary, see here).  So back in May when the FDA unveiled draft proposals on disclosure …

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Jun 18 2010

DIA 2010 – Week in Review

The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location.  In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas of the Agency. As previously mentioned, Will Lee and I attended the meeting.  For those …

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Jun 03 2010

FDA Ups the Ante on Transparency

Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s most recent move on the subject really takes the cake.  If you are in any …

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May 06 2010

Device Advisory Committee Changes

If you don’t like how things are, change it!  You’re not a tree. – Jim Rohn Planning on attending an Advisory Committee meeting for a medical device in the near future?  If you’re a regular at them, you may soon notice something different.  The FDA’s Center for Devices and Radiological Health (CDRH) recently announced some …

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Apr 28 2010

New Disclosure Requirements for FDA Advisory Committees

Seldom, very seldom, does complete truth belong to any human disclosure. – Jane Austen On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees.  If implemented, the draft guidance would increase transparency into the financial disclosures and conflicts of interest of Advisory Committee members. The FDA has 40 …

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Apr 21 2010

FDA-TRACK – The FDA’s FDA-Tracking System

Data is what distinguishes the dilettante from the artist. – George V. Higgins In another move on its transparency initiative, the FDA has recently announced a new program to publicly track its own performance.  It’s called FDA-TRACK and, in the FDA’s own words, its objectives are: Transparency – provide interested parties an unprecedented look into …

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Apr 09 2010

White House Issues Memo on Federal Agencies and Social Media

It isn’t necessary to imagine the world ending in fire or ice. There are two other possibilities: one is paperwork, and the other is nostalgia. – Frank Zappa The White House Office of Information and Regulatory Affairs just released a memo titled:  Social Media, Web-Based Interactive Technologies, and the Paperwork Reduction Act.  Unfortunately, the title …

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Mar 10 2010

Special Protocol Assessments – FDA Transparency vs. Corporate Responsibility

One man’s transparency is another’s humiliation. – Gerry Adams Before I get started, let me be clear:  Transparency is a good thing. After FDA Commissioner Margaret Hamburg took office on 18 May 2009, she wasted no time in pushing for greater transparency at the FDA.  Why?  Events in recent years (such as this, this, and …

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