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Tag Archives: advisory committees
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 … Continue reading
Posted in Industry News, eCTD
Tagged advisory committees, CDRH, FDA, medical devices, transparency
1 Comment
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 – Jane Austen On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees. If implemented, the draft guidance would increase transparency into … Continue reading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
Tips for your Special Protocol Assessment
A number of scientists with greatly different backgrounds can come up with completely different assessments. – Richard Leakey One question that we hear frequently is: Can we apply for a Special Protocol Assessment (SPA) for our Phase 3 trial? The … Continue reading
Posted in FDA
Tagged advisory committees, FDA, guidance, Phase 3, protocol, special protocol assesment
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