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Tag Archives: IND
Pre-IND Submissions in eCTD Format
Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes the IND … Continue reading
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
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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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Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?
UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and … Continue reading
Posted in Clinical Trials, Webinars
Tagged adverse events, bioavailability, bioequivalence, clinical trials, FDA, guidance, IND, pharmacovigilance, safety, webinar
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