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Tag Archives: NDA
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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Is FDA Issuing More Refuse-to-File Letters?
The June 2011 issue of Nature Reviews: Drug Discovery (volume 10, page 403) includes an interesting news brief regarding the apparent increase in Refuse-to-File (RTF) letters being issued by FDA in recent years. In a review of publicly available … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged Cato Research, clinical research, CMC, eCTD, FDA, IND, NDA, refusal to file
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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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New FDA Guidances – February 2011
Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in February 2011 (links go directly to PDF documents). Clinical Pharmacogenomics: Premarketing Evaluation … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged ANDA, cell therapy, clinical trials, FDA, guidance, NDA, REMS, safety
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