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Author Archives: Evan Richardson
FDA Issues New PDF Specifications
In the chaos of the holidays, you might have missed the release of an important new guidance from FDA. On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at … Continue reading
Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies
Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET. Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged biomarkers, Cato Research, clinical trials, drug development, EMA, FDA, pharmacodynamics, pharmacokinetics, Phase 1, Phase 2, pivotal studies, regulatory strategy, webinar
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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
Health Canada Increases Acceptance of eCTD Electronic-only Filings
Late last week, Health Canada (HC) announced that it is further expanding its acceptance of regulatory submissions in the eCTD electronic-only format. In addition the submission types already accepted in eCTD electronic-only format (including those added to the list earlier … 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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