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Tag Archives: transparency
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 … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged biologics, clinical trials, drug product, FDA, FDAAA 2007, IND, regulations, regulatory affairs, safety, transparency
1 Comment
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 … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged clinical trials, FDA, safety, transparency
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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 … Continue reading
Posted in Conferences and Meetings, eCTD, FDA
Tagged adverse events, biomarkers, biotech, cell therapy, clinical development, clinical trials, CMC, comparative effectiveness, data standards, DIA, eCTD, FDA, globalization, in vitro diagnostics, personalized medicine, pharmacokinetics, Phase 1, Phase 2, RPS, study tagging files, transparency
2 Comments
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 … Continue reading
Posted in FDA, Industry News
Tagged 510(k), ANADA, ANDA, biologics, BLA, drugs, exclusivity, FDA, medical devices, NADA, NDA, patent, PMA, transparency
2 Comments
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 eCTD, Industry News
Tagged advisory committees, CDRH, FDA, medical devices, transparency
1 Comment
