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Tag Archives: CMC
Five Keys to Successful Adaptive Trials
This is a guest post by John Johnson, Ph.D. John is a Senior Biostatistician and the Associate Director, Statistics at Cato Research. Running adaptive trials is not easy. However, in a world of skyrocketing drug development costs, these trials are … Continue reading
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, FDA, eCTD
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
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Guidance for the Therapeutic Discovery Tax Credit
Credit you give yourself is not worth having. – Irving Thalberg For all you virtual biotechs and small start-up biotechs that survived the “Great Recession,” here is something to look forward to. I’ve mentioned the Therapeutic Discovery Tax Credit before, … Continue reading
Posted in Industry News
Tagged biomedical, biotech, CMC, FDA, GLP, IRS, Phase 1, Phase 2, pre-IND, tax credit
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Switching from Paper to eCTD Submissions
Despite the many advantages of eCTD submissions, many smaller companies may still be reluctant to take the leap. Concerns over the costs of implementing an eCTD publishing system and the lack of in-house expertise are often the primary stumbling blocks. … Continue reading
Posted in Guest Posts, eCTD
Tagged bookmarks, CFR Part 11, CMC, eCTD, Electronic Submissions Gateway, ESG, hyperlinks, IND, marketing application, NDA
1 Comment
