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Tag Archives: BLA
Transitioning from Paper to eCTD Submissions
A common question that many sponsors ask is, “Can we switch a paper application over to eCTD format?” The short answer is, “Yes.” For a more detailed explanation, check out my new guest post over at GlobalSubmit’s blog, The eCTD … Continue reading
Posted in eCTD, FDA, Guest Posts, Regulatory Strategy
Tagged BLA, eCTD, FDA, GlobalSubmit, IND, NDA, submissions
2 Comments
Free Educational Webinar – Reasons to Switch to eCTD
UPDATE: The webinar slides are now available for download here (PDF). The eCTD format continues to grow as the standard for regulatory submissions worldwide, and the FDA has made it very clear that it prefers to receive submissions in eCTD … Continue reading
Posted in eCTD, Webinars
Tagged BLA, Cato Research, eCTD, FDA, GlobalSubmit, IND, NDA, webinar
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2010 New Drug Approvals
The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 21 new products in 2010 – slightly less than the previous year’s 24 – plus 5 biologics approved by CBER. In light of the FDA’s continued focus on drug safety, I am not surprised that the number isn’t higher. A full list of approvals can be found here.
While the list isn’t long, a few new products stand out to me. Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biologics, BLA, cancer vaccine, CBER, CDER, clinical trials, FDA, marketing application, monoclonal antibody therapy, NDA, safety, vaccines
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OIG Report Shows Increasing Use of Foreign Clinical Trials in Marketing Applications (and Challenges for the FDA)
There are no foreign lands. It is the traveler only who is foreign. – Robert Louis Stevenson Global. That’s one of the buzz words/ideas that has gripped modern drug development. In particular, there is a notion that foreign countries represent … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged biologics, BLA, clinical trials, drug development, FDA, GCP, IND, inspections, marketing application, NDA
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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
