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Tag Archives: transparency
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 – Jane Austen On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees. If implemented, the draft guidance would increase transparency into … Continue reading
Posted in FDA, Industry News
Tagged advisory committees, draft, FDA, guidance, Margaret Hamburg, transparency, waivers
1 Comment
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 … Continue reading
Posted in FDA, Industry News
Tagged BLA, CBER, CDER, CDRH, FDA, FDA-TRACK, IND, NDA, postmarketing, transparency
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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 … Continue reading
Posted in Industry News, Social Media
Tagged FDA, NIH, Paperwork Reduction Act, Social Media, transparency, White House
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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 … Continue reading
Posted in FDA, Industry News
Tagged FDA, guidance, special protocol assesment, transparency
1 Comment
